Home NDC 71821-012 Famotidine
Product NDC 71821-012
11-digit product format 718210012
Labeler code 71821
Product ID 71821-012_0fc43ab9-0e23-258f-e063-6394a90a0c40
Type HUMAN OTC DRUG
Nonproprietary name Famotidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler VKT Pharma Private Limited
Application ANDA215822
Marketing category ANDA
Marketing start 2022-01-28
Substance FAMOTIDINE
Active strength 10 mg/1
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215822-001 FAMOTIDINE FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 A215822-002 FAMOTIDINE FAMOTIDINE 20MG TABLET / ORAL 2022-01-28
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 · 64 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 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 1c564ffb4f44…
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/1
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 199047 Internal RxNorm lookup 310273 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 71821-012-08 Famotidine 288461 in 1 BAG TABLET, FILM COATED 288461 4 71821-012-09 Famotidine 288461 in 1 BAG TABLET, FILM COATED 288461 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71821-012 FAMOTIDINE TABLET, FILM COATED [VKT PHARMA PRIVATE LIMITED] 4 Current NDC, Legacy NDC, 1 package rows 20240126_4e5db906-992f-476b-9d97-63a4c582bbdc.zip 71821-012 FAMOTIDINE TABLET, FILM COATED [VKT PHARMA PRIVATE LIMITED] 1 Current NDC, Legacy NDC, 1 package rows 20240524_1c2cfb3c-eaa0-403f-9589-d706afc06f51.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 · 17 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71821-012-08 71821001208 288461 TABLET, FILM COATED in 1 BAG (71821-012-08) 2022-09-07 0000-00-00 No No Current 71821-012-09 71821001209 288461 TABLET, FILM COATED in 1 BAG (71821-012-09) 2024-05-23 No No Current