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Orange Book drug · Brand (NDA)

Levoxyl

Levothyroxine Sodium

RLDNDA 021301 12 strengths King Pharms
Approved
May 25, 2001
Strengths
12
Listed patents
0

What does the FDA Orange Book show for Levoxyl?

Levoxyl contains Levothyroxine Sodium and is the new drug FDA Orange Book record for NDA 021301. The application has 12 presentations with strength, dosage-form, route, status, RLD/RS, TE, patent, and exclusivity context. Current inventory and clinical labeling are not established without an application-matched source.

FDA application
NDA 021301

New drug application identity from the Orange Book snapshot.

Application holder
King Pharmaceuticals Research And Development LLC

The listed applicant holds the FDA application; this field does not establish the product manufacturer.

Product presentations
12

Each FDA product number remains tied to its own strength, dosage form, route, and status.

Marketing categories
Prescription and Discontinued

Orange Book marketing categories do not establish real-time inventory or commercial availability.

Reference roles
RLD / RS

RLD and RS designations are presentation-specific, not inferred from the trade name.

TE codes
AB1,AB3

Therapeutic-equivalence codes apply only within the matching Orange Book product heading.

Listed patents
0

A zero means none appear in this snapshot, not that no patent rights exist.

Exclusivity records
0

FDA exclusivity and listed patent protection are distinct regulatory concepts.

Sourced from the official FDA Orange Book data file · snapshot refreshed

FDA product-presentation matrix

Every product number in this exact application
Every FDA product presentation under this application, with strength, dosage form and route, marketing status, therapeutic-equivalence code, and reference role.
ProductStrengthDosage form / routeMarketing statusTE codeReference role
0010.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLETORALPrescriptionAB1,AB3
RLD
0020.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLETORALPrescriptionAB1,AB3
RLD
0030.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLETORALPrescriptionAB1,AB3
RLD
0040.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLETORALPrescriptionAB1,AB3
RLD
0050.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLETORALPrescriptionAB1,AB3
RLD
0060.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLETORALPrescriptionAB1,AB3
RLD
0070.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLETORALPrescriptionAB1,AB3
RLD
0080.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLETORALPrescriptionAB1,AB3
RLD
0090.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLETORALPrescriptionAB1,AB3
RLD
0100.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLETORALPrescriptionAB1,AB3
RLD
0110.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine SodiumTABLETORALPrescriptionAB1,AB3
RLDRS
0120.3MGTABLETORALDiscontinuedNone posted
RLD

Marketing status, TE code, RLD, and RS are presentation-level fields. Never transfer one product number's designation to another presentation.

Who is responsible for this application?

Application holder is not the same as manufacturer

FDA application holder

King Pharmaceuticals Research And Development LLC

The Orange Book identifies this organization as the applicant responsible for NDA 021301.

Manufacturer status

Not established by the Orange Book

A product-specific FDA label or NDC source must independently identify a manufacturer, labeler, distributor, packager, repackager, or relabeler. The applicant name is not used as a substitute for that evidence.

Regulatory interpretation

What the record means, and what it does not
FDA marketing status

Status varies by presentation: 11 prescription and 1 on the Discontinued Drug Product List

Orange Book status is assigned at the product-presentation level, so one strength can remain listed as prescription or OTC while another appears on the discontinued list.

Therapeutic equivalence

TE code AB1,AB3 across rated presentations

FDA considers products with the same AB1,AB3 code therapeutically equivalent within the same active ingredient, dosage form, route, and strength heading. A different numbered AB code is a different equivalence group. 1 presentation in the application has no posted TE code.

Patent & exclusivity record

No listed patents or exclusivity records

This means none appear for this application in the current Orange Book files. It is not a freedom-to-operate opinion and does not rule out unlisted patents, regulatory barriers, or product-specific rights.

Same-ingredient landscape

19 other ANDAs and 13 other NDAs found

12 of the related ANDA applications are not marked discontinued. Sharing an ingredient does not establish pharmaceutical or therapeutic equivalence; strength, dosage form, route, and TE group still matter.

Which products are meaningfully comparable?

Exact ingredient + dosage form + route cohorts

NDA 021301 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Why are clinical sections unavailable?

Exact application-label matching status
Exact source match queuedQueue NDA-021301

No exact application-level FDA or DailyMed label match has been reviewed for this application. Approved uses, dosing, warnings, adverse reactions, and clinical evidence remain unavailable rather than being inherited from a related brand, generic, or ingredient record.

Until an exact application match passes human review, this page intentionally omits approved uses, dosing, warnings, adverse reactions, mechanism, and clinical-study summaries. It never inherits those claims from an RLD, brand, generic, or same-ingredient product.

Strengths & dosage forms

12 approved presentations · NDA 021301
TE AB1,AB3RLD
Strength
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription

Key dates

Approval, patents, exclusivity

  1. Approval

    FDA approval date of this drug product.

    25 yr 6 mo ago

  2. Today

Pharmaceutical detail

FDA product record

Active ingredient

LEVOTHYROXINE SODIUM

Strength

0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Dosage form

TABLET

Route

ORAL

TE code

AB1,AB3

Application

NDA 021301

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Listed patents

Orange Book patent file

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Active-ingredient family

Brand + generics

This is a reference-listed drug (RLD), the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Levothyroxine Sodium family

How to use this record responsibly

Scope, limitations, and primary sources

What to verify before making a decision

  • The applicant is the holder of legal responsibility for the application; the Orange Book does not establish that the applicant manufactured or currently markets every listed product.
  • RX, OTC, and discontinued are FDA listing categories, not real-time pharmacy inventory or commercial-availability data.
  • Therapeutic equivalence applies only within the matching ingredient, dosage form, route, strength, and TE-code group; same ingredient alone is insufficient.
  • Listed patent and exclusivity dates are regulatory intelligence, not legal advice, a freedom-to-operate analysis, or a reliable generic-launch forecast.
  • The Orange Book is not prescribing information and does not provide indications, dosing, contraindications, adverse reactions, recalls, or current safety communications.

Official FDA references

Data shown here is normalized for search and comparison. When a regulatory, substitution, launch, or legal decision turns on a field, verify it against the current FDA record and the relevant source document.

Levoxyl: frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this drug, from the FDA Orange Book.

Built directly from the FDA Orange Book product, patent, and exclusivity files refreshed Jul 02, 2026, 06:34 PM. Every strength of NDA 021301 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.

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