Orange Book product · Brand (NDA)
PEPCID PRESERVATIVE FREE
FAMOTIDINE
At a glance
Nov 04, 1986
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 04, 1986
40 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
FAMOTIDINE
Strength
10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 019510
Product number
004
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2025FAMOTIDINEBrand (NDA)
NDA 219935 · SAGENT
- 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
- 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.
