Home NDC 64980-623 Famotidine
Product NDC 64980-623
11-digit product format 649800623
Labeler code 64980
Product ID 64980-623_3f43a0a4-1606-4d45-95c0-46b73e504010
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famotidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA218181
Marketing category ANDA
Marketing start 2024-05-06
Substance FAMOTIDINE
Active strength 20 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 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 A218181-001 FAMOTIDINE FAMOTIDINE 20MG TABLET / ORAL AB 2023-12-22 A218181-002 FAMOTIDINE FAMOTIDINE 40MG TABLET / ORAL AB 2023-12-22
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.
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 A218181-001 FAMOTIDINE 20MG TABLET / ORAL AB 2023-12-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218181-002 FAMOTIDINE 40MG TABLET / ORAL AB 2023-12-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218181-001 FAMOTIDINE 20MG TABLET / ORAL AB 2023-12-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218181-002 FAMOTIDINE 40MG TABLET / ORAL AB 2023-12-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218181-001 FAMOTIDINE 20MG TABLET / ORAL AB 2023-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218181-002 FAMOTIDINE 40MG TABLET / ORAL AB 2023-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218181-001 FAMOTIDINE 20MG TABLET / ORAL AB 2023-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218181-002 FAMOTIDINE 40MG TABLET / ORAL AB 2023-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218181-001 FAMOTIDINE 20MG TABLET / ORAL AB 2023-12-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218181-002 FAMOTIDINE 40MG TABLET / ORAL AB 2023-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218181-001 FAMOTIDINE 20MG TABLET / ORAL AB 2023-12-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218181-002 FAMOTIDINE 40MG TABLET / ORAL AB 2023-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218181-001 FAMOTIDINE 20MG TABLET / ORAL AB 2023-12-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218181-002 FAMOTIDINE 40MG TABLET / ORAL AB 2023-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218181-001 FAMOTIDINE 20MG TABLET / ORAL AB 2023-12-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218181-002 FAMOTIDINE 40MG TABLET / ORAL AB 2023-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218181-001 FAMOTIDINE 20MG TABLET / ORAL AB 2023-12-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218181-002 FAMOTIDINE 40MG TABLET / ORAL AB 2023-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218181-001 FAMOTIDINE 20MG TABLET / ORAL AB 2023-12-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218181-002 FAMOTIDINE 40MG TABLET / ORAL AB 2023-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218181-001 FAMOTIDINE 20MG TABLET / ORAL AB 2023-12-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218181-002 FAMOTIDINE 40MG TABLET / ORAL AB 2023-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218181-001 FAMOTIDINE 20MG TABLET / ORAL AB 2023-12-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218181-002 FAMOTIDINE 40MG TABLET / ORAL AB 2023-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218181-001 FAMOTIDINE 20MG TABLET / ORAL AB 2023-12-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218181-002 FAMOTIDINE 40MG TABLET / ORAL AB 2023-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218181-001 FAMOTIDINE 20MG TABLET / ORAL AB 2023-12-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218181-002 FAMOTIDINE 40MG TABLET / ORAL AB 2023-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218181-001 FAMOTIDINE 20MG TABLET / ORAL AB 2023-12-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218181-002 FAMOTIDINE 40MG TABLET / ORAL AB 2023-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218181-001 FAMOTIDINE 20MG TABLET / ORAL AB 2023-12-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A218181-002 FAMOTIDINE 40MG TABLET / ORAL AB 2023-12-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A218181-001 FAMOTIDINE 20MG TABLET / ORAL AB 2023-12-22 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A218181-002 FAMOTIDINE 40MG TABLET / ORAL AB 2023-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A218181-001 FAMOTIDINE 20MG TABLET / ORAL AB 2023-12-22 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A218181-002 FAMOTIDINE 40MG TABLET / ORAL AB 2023-12-22 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218181-001 FAMOTIDINE 20MG TABLET / ORAL AB 2023-12-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218181-002 FAMOTIDINE 40MG TABLET / ORAL AB 2023-12-22 a50c72e98297…
Observed Orange Book normalized TE history# 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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FAMOTIDINE 20 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 284245 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 64980-623-01 Famotidine 100 in 1 BOTTLE TABLET, FILM COATED 100 1 64980-623-10 Famotidine 1000 in 1 BOTTLE TABLET, FILM COATED 1000 1 64980-623-50 Famotidine 500 in 1 BOTTLE TABLET, FILM COATED 500 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-623 FAMOTIDINE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] 1 Current NDC, 3 package rows 20240606_15b87f7f-1abf-4d8a-bdbe-03bea0021a68.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 Marketing start Sample Exclude flag Status 64980-623-01 64980062301 100 TABLET, FILM COATED in 1 BOTTLE (64980-623-01) 2024-05-06 No No Current 64980-623-10 64980062310 1000 TABLET, FILM COATED in 1 BOTTLE (64980-623-10) 2024-05-06 No No Current 64980-623-50 64980062350 500 TABLET, FILM COATED in 1 BOTTLE (64980-623-50) 2024-05-06 No No Current