Home NDC 0338-5197 Famotidine
Product NDC 0338-5197
11-digit product format 003385197
Labeler code 0338
Product ID 0338-5197_bb9e28a8-1076-4c48-9a19-cc43bcd64862
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famotidine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application ANDA075591
Marketing category ANDA
Marketing start 2001-05-10
Substance FAMOTIDINE
Active strength 20 mg/50mL
Pharmacologic classes Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER FAMOTIDINE 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10
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.
Product history page 1 of 2 · 41 observed 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 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075591-001 FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER 0.4MG/ML INJECTABLE / INJECTION RS 2001-05-10 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Famotidine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FAMOTIDINE 20 mg/50mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199739 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 0338-5197-41 Famotidine 12 in 1 CARTON INJECTION, SOLUTION 12 20 0338-5197-41 Famotidine 50 mL in 1 BAG INJECTION, SOLUTION 50 20
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0338-5197 FAMOTIDINE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 19 Current NDC, Legacy NDC, 2 package rows 20250507_97c33213-f415-4718-8466-9aa50371af70.zip
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 0338-5197-41 00338519741 12 BAG in 1 CARTON (0338-5197-41) / 50 mL in 1 BAG 12 bag 2001-05-10 0000-00-00 No No Current