Home NDC 55648-937 Famotidine
Product NDC 55648-937
11-digit product format 556480937
Labeler code 55648
Product ID 55648-937_b0208b67-58f7-4e87-9dc2-48cb6d9d9790
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famotidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Wockhardt Limited
Application ANDA075786
Marketing category ANDA
Marketing start 2001-04-16
Marketing end 0000-00-00
Substance FAMOTIDINE
Active strength 40 mg/1
Pharmacologic classes Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 2 · 88 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A075786-001 FAMOTIDINE FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 A075786-002 FAMOTIDINE FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16
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 3 · 88 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 2026-10-15 13:18:30 2026-09 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 c2088c7a36db…2026-09-14 22:38:34 2026-08 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55648-937-01 Famotidine 30 in 1 BOTTLE TABLET, FILM COATED 30 2 55648-937-02 Famotidine 100 in 1 BOTTLE TABLET, FILM COATED 100 2 55648-937-03 Famotidine 1000 in 1 BOTTLE TABLET, FILM COATED 1000 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FAMOTIDINE ACTIVE INGREDIENT 5QZO15J2Z8 FAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 FAMOTIDINE ACTIVE MOIETY 5QZO15J2Z8 FAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 FAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT FAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 FAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ FAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U FAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55648-937 FAMOTIDINE TABLET, FILM COATED [WOCKHARDT LIMITED] 2 Legacy NDC, 3 package rows 20120907_199c7249-4ffa-4889-a53a-ffd58653914f.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 Status 55648-937-01 55648093701 30 in 1 BOTTLE Historical 55648-937-02 55648093702 100 in 1 BOTTLE Historical 55648-937-03 55648093703 1000 in 1 BOTTLE Historical