Home NDC 72789-453 FAMOTIDINE
Product NDC 72789-453
11-digit product format 727890453
Labeler code 72789
Product ID 72789-453_57d534f4-024f-5742-e063-6394a90ac57a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FAMOTIDINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA215630
Marketing category ANDA
Marketing start 2023-08-23
Substance FAMOTIDINE
Active strength 40 mg/1
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 43 .
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 A215630-001 FAMOTIDINE FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 A215630-002 FAMOTIDINE FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 68 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 2026-09-14 22:38:34 2026-08 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 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 40 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 284245 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 72789-453-30 FAMOTIDINE 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-453 FAMOTIDINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 4 Current NDC, 1 package rows 20250410_a0f38398-4d34-4ecc-8a6a-37732adaaad3.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 2 of 2 · 22 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72789-453-30 72789045330 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-453-30) 2024-11-14 No No Current