Home NDC 33261-562 Famotidine
Product NDC 33261-562
11-digit product format 332610562
Labeler code 33261
Product ID 33261-562_316b2807-6d53-4d3d-9346-064bccd2fd60
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famotidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aidarex Pharmaceuticals LLC
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 No
Listing certified through 2019-12-31
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 · 63 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 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 · 86 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 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…2019-12-13 00:20 UTC 2019-12 A075786-001 FAMOTIDINE 20MG TABLET / ORAL AB 2001-04-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075786-002 FAMOTIDINE 40MG TABLET / ORAL AB 2001-04-16 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 3 · 86 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 33261-562-30 Famotidine 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 1 33261-562-90 Famotidine 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FAMOTIDINE ACTIVE INGREDIENT 5QZO15J2Z8 FAMOTIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 FAMOTIDINE ACTIVE MOIETY 5QZO15J2Z8 FAMOTIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FAMOTIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 FAMOTIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FAMOTIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FAMOTIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ FAMOTIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FAMOTIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U FAMOTIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FAMOTIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33261-562 FAMOTIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 Legacy NDC, 2 package rows 20140107_6d9d43c7-6680-4d5a-bc91-b7510f2f8b6a.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 33261-562-30 33261056230 30 in 1 BOTTLE, PLASTIC Historical 33261-562-90 33261056290 90 in 1 BOTTLE, PLASTIC Historical