Home NDC 25021-756 Famotidine
Product NDC 25021-756
11-digit product format 250210756
Labeler code 25021
Product ID 25021-756_82835fd5-d117-4b63-82c2-fe5642fc04dd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famotidine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sagent Pharmaceuticals
Application NDA219935
Marketing category NDA
Marketing start 2025-10-15
Marketing end 2027-03-31
Substance FAMOTIDINE
Active strength 4 mg/mL
Pharmacologic classes Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219935-001 FAMOTIDINE FAMOTIDINE 20MG/5ML (4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-07-16 N219935-002 FAMOTIDINE FAMOTIDINE 40MG/10ML (4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-07-16 N219935-003 FAMOTIDINE FAMOTIDINE 200MG/50ML (4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-07-16
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N219935-001 FAMOTIDINE 20MG/5ML (4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219935-002 FAMOTIDINE 40MG/10ML (4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219935-003 FAMOTIDINE 200MG/50ML (4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219935-001 FAMOTIDINE 20MG/5ML (4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219935-002 FAMOTIDINE 40MG/10ML (4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N219935-003 FAMOTIDINE 200MG/50ML (4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N219935-001 FAMOTIDINE 20MG/5ML (4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219935-002 FAMOTIDINE 40MG/10ML (4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-07-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N219935-003 FAMOTIDINE 200MG/50ML (4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-07-16 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219935-001 FAMOTIDINE 20MG/5ML (4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-07-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219935-002 FAMOTIDINE 40MG/10ML (4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-07-16 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219935-003 FAMOTIDINE 200MG/50ML (4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-07-16 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Famotidine Active Ingredients# Ingredient, Strength table Ingredient Strength FAMOTIDINE 4 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5QZO15J2Z8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2727402 Internal RxNorm lookup 2727403 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 25021-756-10 Famotidine 10 mL in 1 VIAL INJECTION, SOLUTION 10 5 25021-756-10 Famotidine 10 in 1 CARTON INJECTION, SOLUTION 10 5 25021-756-50 Famotidine 1 in 1 CARTON INJECTION, SOLUTION 1 5 25021-756-50 Famotidine 50 mL in 1 VIAL INJECTION, SOLUTION 50 5
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 25021-756-10 25021075610 10 VIAL in 1 CARTON (25021-756-10) / 10 mL in 1 VIAL 10 vial 2025-10-15 2027-03-31 No No Historical 25021-756-50 25021075650 1 VIAL in 1 CARTON (25021-756-50) / 50 mL in 1 VIAL 1 vial 2025-10-15 2027-02-28 No No Historical