Home NDC 68094-054-65 Famotidine
Product NDC 68094-054
Requested package NDC 68094-054-65
11-digit product format 680940054
Labeler code 68094
Product ID 68094-054_85fb9c19-0c02-4c0e-8f80-ecead1578723
Type HUMAN OTC DRUG
Nonproprietary name FAMOTIDINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Precision Dose, Inc.
Application ANDA077351
Marketing category ANDA
Marketing start 2024-03-28
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 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 A077351-001 FAMOTIDINE FAMOTIDINE 20MG TABLET / ORAL 2006-09-25
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 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077351-001 FAMOTIDINE 20MG TABLET / ORAL 2006-09-25 cb3db0bc1861…
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 68094-054-59 Famotidine 10 in 1 BLISTER PACK TABLET, FILM COATED 10 3 68094-054-65 Famotidine 20 in 1 CARTON TABLET, FILM COATED 20 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68094-054 FAMOTIDINE TABLET, FILM COATED [PRECISION DOSE, INC.] 3 Current NDC, 2 package rows 20250529_de42b6c4-c44b-4ec1-b505-fc5266452d57.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 3 · 42 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68094-054-65 68094005465 20 BLISTER PACK in 1 CARTON (68094-054-65) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-054-59) 20 blister pack 2024-03-28 No No Current