Orange Book product · Brand (NDA)
FAMOTIDINE
FAMOTIDINE
At a glance
Jul 16, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 16, 2025
11 mo ago
Today
Pharmaceutical detail
Active ingredient
FAMOTIDINE
Strength
20MG/5ML (4MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 219935
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2004FLUXIDBrand (NDA)
NDA 021712 · UCB INC
- 1998PEPCID ACBrand (NDA)
NDA 020801 · KENVUE BRANDS
- 1994PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINERBrand (NDA)
NDA 020249 · MERCK SHARP DOHME
- 1987PEPCIDBrand (NDA)
NDA 019527 · SALIX PHARMS
- 1986PEPCIDBrand (NDA)
NDA 019510 · MERCK
- 2026FAMOTIDINEGeneric (ANDA)
ANDA 217432 · LUPIN
- 2026FAMOTIDINEGeneric (ANDA)
ANDA 219603 · CONTRACT PHARMACAL
- 2025FAMOTIDINEGeneric (ANDA)
ANDA 219863 · MSN
- 2025FAMOTIDINEGeneric (ANDA)
ANDA 219091 · AUROBINDO PHARMA LTD
- 2025FAMOTIDINEGeneric (ANDA)
ANDA 219153 · BIONPHARMA
- 2025FAMOTIDINEGeneric (ANDA)
ANDA 217982 · LANNETT CO INC
- 2024FAMOTIDINEGeneric (ANDA)
ANDA 218344 · EPIC PHARMA LLC
Listed patents
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.
