Home NDC 63323-738 Famotidine
Product NDC 63323-738
11-digit product format 633230738
Labeler code 63323
Product ID 63323-738_14c82153-53c9-4457-8cd3-fbb045885412
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FAMOTIDINE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA075709
Marketing category ANDA
Marketing start 2001-07-19
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 A075709-001 FAMOTIDINE FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 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 A075709-001 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 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 c2088c7a36db…2026-09-14 22:38:34 2026-08 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075709-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 3a93d1ddd44b…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 A075709-001 AP 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075709-001 AP 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075709-001 AP 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075709-001 AP 1 a50c72e98297…
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 204441 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 63323-738-03 Famotidine 4 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 4 6 63323-738-06 Famotidine 20 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 20 6 63323-738-09 Famotidine 10 in 1 TRAY INJECTION, SOLUTION 10 6 63323-738-20 Famotidine 10 in 1 TRAY INJECTION, SOLUTION 10 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FAMOTIDINE ACTIVE INGREDIENT 5QZO15J2Z8 FAMOTIDINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 FAMOTIDINE ACTIVE MOIETY 5QZO15J2Z8 FAMOTIDINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 ASPARTIC ACID INACTIVE INGREDIENT 30KYC7MIAI FAMOTIDINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH FAMOTIDINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A FAMOTIDINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-738 FAMOTIDINE (FAMOTIDINE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] 6 Current NDC, Legacy NDC, 4 package rows 20221027_5995d726-f3f8-4c2d-af19-1b12e3f769c6.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 63323-738-03 63323073803 4 mL in 1 VIAL, MULTI-DOSE 4 ml Historical 63323-738-06 63323073806 20 mL in 1 VIAL, MULTI-DOSE 20 ml Historical 63323-738-09 63323073809 10 VIAL, MULTI-DOSE in 1 TRAY (63323-738-09) / 4 mL in 1 VIAL, MULTI-DOSE (63323-738-03) 2001-07-19 0000-00-00 No No Current 63323-738-20 63323073820 10 VIAL, MULTI-DOSE in 1 TRAY (63323-738-20) / 20 mL in 1 VIAL, MULTI-DOSE (63323-738-06) 2001-07-19 0000-00-00 No No Current