FDA application holder
Samson Medical Technologies LLC
The Orange Book identifies this organization as the applicant responsible for ANDA 065251.
Orange Book drug · Generic (ANDA)
Cefuroxime Sodium In Plastic Container
Cefuroxime Sodium
DiscontinuedANDA 065251 2 strengths Samson Medcl
Approved
Dec 30, 2009
Strengths
2
Listed patents
0
What does the FDA Orange Book show for Cefuroxime Sodium In Plastic Container?
Cefuroxime Sodium In Plastic Container contains Cefuroxime Sodium and is the generic drug FDA Orange Book record for ANDA 065251. The application has 2 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
- ANDA 065251
- Application holder
- Samson Medical Technologies LLC
- Product presentations
- 2
- Marketing categories
- Discontinued
- Reference roles
- None posted
- TE codes
- None posted
- Listed patents
- 0
- Exclusivity records
- 0
Abbreviated new drug application identity from the Orange Book snapshot.
The listed applicant holds the FDA application; this field does not establish the product manufacturer.
Each FDA product number remains tied to its own strength, dosage form, route, and status.
Orange Book marketing categories do not establish real-time inventory or commercial availability.
RLD and RS designations are presentation-specific, not inferred from the trade name.
Therapeutic-equivalence codes apply only within the matching Orange Book product heading.
A zero means none appear in this snapshot, not that no patent rights exist.
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
| Product | Strength | Dosage form / route | Marketing status | TE code | Reference role |
|---|---|---|---|---|---|
| 001 | EQ 75GM BASE/VIAL | INJECTABLEINJECTION | Discontinued | None posted | None posted |
| 002 | EQ 225GM BASE/VIAL | INJECTABLEINJECTION | Discontinued | None posted | None posted |
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
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
2 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
16 other ANDAs and 3 other NDAs found
2 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
ANDA 065251 appears in 1 comparison cohort. These groups narrow the same-ingredient landscape, but strength and TE code must still match before interpreting therapeutic equivalence.
Injectable · Injection
Cefuroxime Sodium
- Product rows
- 24
- Active applications
- 2
- Active with AB row
- 0
Why are clinical sections unavailable?
Exact application-label matching status
Exact source match queuedQueue ANDA-065251
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
2 approved presentations · ANDA 065251
Discontinued
- Strength
- EQ 75GM BASE/VIAL
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Discontinued
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
16 yr 10 mo ago
Today
Pharmaceutical detail
FDA product recordActive ingredient
CEFUROXIME SODIUM
Strength
EQ 75GM BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 065251
Product number
001
Marketing status
Discontinued
Reference listed drug (RLD)
No
Reference standard (RS)
No
Listed patents
Orange Book patent fileNo 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.
Discontinued
- Strength
- EQ 225GM BASE/VIAL
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Discontinued
Key dates
Approval, patents, exclusivityApproval
FDA approval date of this drug product.
16 yr 10 mo ago
Today
Pharmaceutical detail
FDA product recordActive ingredient
CEFUROXIME SODIUM
Strength
EQ 225GM BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 065251
Product number
002
Marketing status
Discontinued
Reference listed drug (RLD)
No
Reference standard (RS)
No
Listed patents
Orange Book patent fileNo 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
Generic (ANDA) of Cefuroxime Sodium
- 2001Cefuroxime And Dextrose In Duplex ContainerBrand (NDA)
NDA 050780 · B Braun
- 1989Zinacef In Plastic ContainerBrand (NDA)
NDA 050643 · Pai Holdings Pharm
- 1983ZinacefBrand (NDA)
NDA 050558 · Pai Holdings Pharm
- 2008Cefuroxime SodiumGeneric (ANDA)
ANDA 065483 · Hospira Inc
- 2008Cefuroxime SodiumGeneric (ANDA)
ANDA 065503 · Hospira Inc
- 2008Cefuroxime SodiumGeneric (ANDA)
ANDA 065484 · Hospira Inc
- 2004Cefuroxime SodiumGeneric (ANDA)
ANDA 065048 · Hikma
- 2004Cefuroxime SodiumGeneric (ANDA)
ANDA 065046 · Hikma
- 2001Cefuroxime SodiumGeneric (ANDA)
ANDA 065001 · Fresenius Kabi USA
- 1998Cefuroxime SodiumGeneric (ANDA)
ANDA 065002 · Fresenius Kabi USA
- 1998Cefuroxime SodiumGeneric (ANDA)
ANDA 064191 · Teva Pharms
- 1998Cefuroxime SodiumGeneric (ANDA)
ANDA 064192 · Teva Pharms
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
- Electronic Orange Book record
- Orange Book preface and TE-code policy
- FDA product, patent, and exclusivity data files
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.
Cefuroxime Sodium In Plastic Container: 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 ANDA 065251 is shown on this page. Interpret patents, exclusivity, availability, and therapeutic equivalence using the limitations above.
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