Home NDC 63323-739 Famotidine
Product NDC 63323-739
11-digit product format 633230739
Labeler code 63323
Product ID 63323-739_241710d5-bcef-4852-a09c-0e681250e6aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famotidine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA075813
Marketing category ANDA
Marketing start 2001-03-15
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 42 .
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 A075813-001 FAMOTIDINE PRESERVATIVE FREE 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 A075813-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075813-001 FAMOTIDINE PRESERVATIVE FREE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 63323-739-16 Famotidine 25 in 1 TRAY INJECTION, SOLUTION 25 7 63323-739-41 Famotidine 2 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 2 7 63323-739-11 Famotidine 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 6 63323-739-12 Famotidine 25 in 1 TRAY INJECTION, SOLUTION 25 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 INGREDIENT 5QZO15J2Z8 FAMOTIDINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 FAMOTIDINE ACTIVE MOIETY 5QZO15J2Z8 FAMOTIDINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 FAMOTIDINE ACTIVE MOIETY 5QZO15J2Z8 FAMOTIDINE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 ASPARTIC ACID INACTIVE INGREDIENT 30KYC7MIAI FAMOTIDINE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 1 ASPARTIC ACID INACTIVE INGREDIENT 30KYC7MIAI FAMOTIDINE INJECTION, SOLUTION [FRESENIUS KABI USA, 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 63323-739 FAMOTIDINE (FAMOTIDINE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] 7 Current NDC, Legacy NDC, 2 package rows 20210813_ce533636-cc9b-45d0-87a6-5390377ff28a.zip 63323-739 FAMOTIDINE (FAMOTIDINE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] 6 Current NDC, Legacy NDC, 2 package rows 20221110_aeb27cea-1ff7-4a6e-93f1-d4c4dac5faa7.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 · 3 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 63323-739-11 63323073911 2 mL in 1 VIAL, SINGLE-DOSE 2 ml Historical 63323-739-12 63323073912 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-739-12) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-739-11) 2001-03-15 0000-00-00 No No Current 63323-739-16 63323073916 25 VIAL, SINGLE-USE in 1 TRAY (63323-739-16) / 2 mL in 1 VIAL, SINGLE-USE (63323-739-41) 2001-03-15 0000-00-00 No No Current 63323-739-41 63323073941 2 mL in 1 VIAL, SINGLE-USE 2 ml Historical