Orange Book drug · Brand (NDA)

Dolophine Hydrochloride

Methadone Hydrochloride

DiscontinuedRLDNDA 006134 3 strengths Hikma

Approved

Prior to Jan 1, 1982

Strengths

Listed patents

What does the FDA Orange Book show for Dolophine Hydrochloride?

Dolophine Hydrochloride contains Methadone Hydrochloride and is the new drug FDA Orange Book record for NDA 006134. The application has 3 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 006134
Application holder: Hikma Pharmaceuticals USA Inc
Product presentations: 3
Marketing categories: Discontinued
Reference roles: RLD
TE codes: None posted
Listed patents: 0
Exclusivity records: 0

Sourced from the official FDA Orange Book data file · snapshot refreshed Jul 02, 2026, 06:34 PM

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.
Product	Strength	Dosage form / route	Marketing status	TE code	Reference role
002	5MG	TABLETORAL	Discontinued	None posted	RLD
004	10MG/30ML	SYRUPORAL	Discontinued	None posted	None posted
010	10MG	TABLETORAL	Discontinued	None 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

Hikma Pharmaceuticals USA Inc

The Orange Book identifies this organization as the applicant responsible for NDA 006134.

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

3 presentations listed as on the Discontinued Drug Product List

A discontinued-list entry does not, by itself, show why marketing stopped or whether FDA determined the product was withdrawn for safety or effectiveness.

Therapeutic equivalence

No TE code is posted for this application

No TE code does not mean FDA found the product ineffective or non-equivalent. FDA generally publishes TE evaluations for multisource prescription products; single-source and some other products may have no 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

28 other ANDAs and 5 other NDAs found

23 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 006134 appears in 2 comparison cohorts. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.

Syrup · Oral

Methadone Hydrochloride

1 application

Product rows: 1
Active applications: 0
Active with AB row: 0

Tablet · Oral

Methadone Hydrochloride

13 applications

Product rows: 24
Active applications: 8
Active with AB row: 0

Methadone Hydrochloride · ANDA 090635 Methadone Hydrochloride · ANDA 204166 Methadone Hydrochloride · ANDA 211228 Methadone Hydrochloride · ANDA 210484 Methadone Hydrochloride · ANDA 208305 Methadone Hydrochloride · ANDA 203502

Why are clinical sections unavailable?

Exact application-label matching status

Exact source match queuedQueue NDA-006134

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

3 approved presentations · NDA 006134

RLDDiscontinued

Strength: 5MG
Dosage form: TABLET
Route: ORAL
Marketing status: Discontinued

Key dates

Approval, patents, exclusivity

No patent or exclusivity dates are listed for this product.

Pharmaceutical detail

FDA product record

Active ingredient

METHADONE HYDROCHLORIDE

Strength

5MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 006134

Product number

002

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

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 Methadone Hydrochloride 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.