Home NDC 67457-448 Famotidine
Product NDC 67457-448
11-digit product format 674570448
Labeler code 67457
Product ID 67457-448_8845646e-1471-490d-a26b-f18c7e31a4c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famotidine
Dosage form INJECTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA078641
Marketing category ANDA
Marketing start 2008-06-26
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A078641-001 FAMOTIDINE FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078641-001 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 · 44 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 2026-10-15 13:18:30 2026-09 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078641-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2008-06-25 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Famotidine
Listing expiration 2027-12-31 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 67457-448-00 Famotidine 4 mL in 1 VIAL INJECTION 4 6 67457-448-43 Famotidine 10 in 1 CARTON INJECTION 10 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-448 FAMOTIDINE INJECTION [MYLAN INSTITUTIONAL LLC] 5 Current NDC, Legacy NDC, 2 package rows 20201219_e3b13e23-122b-4bd4-95cf-b5a14b7afc05.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 67457-448-00 67457044800 4 mL in 1 VIAL 4 ml Historical 67457-448-43 67457044843 10 VIAL in 1 CARTON (67457-448-43) / 4 mL in 1 VIAL (67457-448-00) 10 vial 2008-06-26 0000-00-00 No No Current