Home NDC 70860-753 Famotidine
Product NDC 70860-753
11-digit product format 708600753
Labeler code 70860
Product ID 70860-753_546575de-cef0-45ca-a440-2a3d8d34fdc9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name famotidine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Athenex Pharmaceutical Division, LLC.
Application ANDA075651
Marketing category ANDA
Marketing start 2020-08-10
Marketing end 0000-00-00
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 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70860-753-20 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70860-753-20 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 70860-753-20 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 70860-753-20 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 70860-753-20 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 70860-753-20 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70860-753-20 302b2466d912…e7b80fea0513…
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 A075651-001 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 A075651-001 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 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075651-001 FAMOTIDINE 10MG/ML INJECTABLE / INJECTION AP 2001-04-16 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70860-753-20 Famotidine 10 in 1 CARTON INJECTION, SOLUTION 10 5 70860-753-41 Famotidine 20 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 20 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70860-753 FAMOTIDINE INJECTION, SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.] 5 Legacy NDC, 2 package rows 20250130_234d941f-5754-4d83-b02e-26638e0054e6.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 70860-753-20 70860075320 10 VIAL, MULTI-DOSE in 1 CARTON (70860-753-20) > 20 mL in 1 VIAL, MULTI-DOSE (70860-753-41) 2020-08-10 0000-00-00 No No Current 70860-753-41 70860075341 20 mL in 1 VIAL, MULTI-DOSE 20 ml Historical