Home NDC 55319-409-03 Famotidine
Product NDC 55319-409
Requested package NDC 55319-409-03
11-digit product format 553190409
Labeler code 55319
Product ID 55319-409_99698eea-6bf1-42e8-9f48-d58fc0437324
Type HUMAN OTC DRUG
Nonproprietary name Famotidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler FAMILY DOLLAR
Application ANDA215822
Marketing category ANDA
Marketing start 2025-09-01
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 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 · 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 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215822-001 FAMOTIDINE 10MG TABLET / ORAL 2022-01-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215822-002 FAMOTIDINE 20MG TABLET / ORAL 2022-01-28 caaa826d4ba7…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…
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 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 55319-409-01 Famotidine 1 in 1 CARTON TABLET, FILM COATED 1 1 55319-409-01 Famotidine 25 in 1 BOTTLE TABLET, FILM COATED 25 1 55319-409-02 Famotidine 50 in 1 BOTTLE TABLET, FILM COATED 50 1 55319-409-02 Famotidine 1 in 1 CARTON TABLET, FILM COATED 1 1 55319-409-03 Famotidine 100 in 1 BOTTLE TABLET, FILM COATED 100 1 55319-409-03 Famotidine 1 in 1 CARTON TABLET, FILM COATED 1 1
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 · 16 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 55319-409-03 55319040903 1 BOTTLE in 1 CARTON (55319-409-03) / 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2025-09-01 No No Current