Home NDC 0641-6023 Famotidine
Product NDC 0641-6023
11-digit product format 006416023
Labeler code 0641
Product ID 0641-6023_021158a6-1da8-477a-af20-4ce26c147b32
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famotidine
Dosage form INJECTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA075488
Marketing category ANDA
Marketing start 2001-04-16
Substance FAMOTIDINE
Active strength 10 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075488-001 FAMOTIDINE FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075488-001 AP
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 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075488-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP RS 2001-04-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Famotidine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FAMOTIDINE 10 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 204441 Internal RxNorm lookup 1743833 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 0641-6023-01 Famotidine 4 mL in 1 VIAL INJECTION 4 9 0641-6023-10 Famotidine 10 in 1 CARTON INJECTION 10 9 0641-6023-25 Famotidine 25 in 1 CARTON INJECTION 25 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-6023 FAMOTIDINE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 9 Current NDC, Legacy NDC, 3 package rows 20240410_1fdf16e5-145d-4c19-a318-fc6c10794b50.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 0641-6023-01 00641602301 4 mL in 1 VIAL 4 ml Historical 0641-6023-10 00641602310 10 VIAL in 1 CARTON (0641-6023-10) / 4 mL in 1 VIAL (0641-6023-01) 10 vial 2023-05-16 No No Current 0641-6023-25 00641602325 25 VIAL in 1 CARTON (0641-6023-25) / 4 mL in 1 VIAL (0641-6023-01) 25 vial 2001-04-16 0000-00-00 No No Current