Home NDC 68071-3420 FAMOTIDINE
Product NDC 68071-3420
11-digit product format 680713420
Labeler code 68071
Product ID 68071-3420_1bf9ddc8-fe69-c02a-e063-6394a90a7149
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FAMOTIDINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA215630
Marketing category ANDA
Marketing start 2022-07-08
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 A215630-001 FAMOTIDINE FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 A215630-002 FAMOTIDINE FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07
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 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 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215630-001 FAMOTIDINE 20MG TABLET / ORAL AB 2022-01-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A215630-002 FAMOTIDINE 40MG TABLET / ORAL AB 2022-01-07 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 observed states.
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 · 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 68071-3420-3 FAMOTIDINE 30 in 1 BOTTLE TABLET, FILM COATED 30 5 68071-3420-6 FAMOTIDINE 60 in 1 BOTTLE TABLET, FILM COATED 60 5 68071-3420-7 FAMOTIDINE 14 in 1 BOTTLE TABLET, FILM COATED 14 5 68071-3420-8 FAMOTIDINE 120 in 1 BOTTLE TABLET, FILM COATED 120 5 68071-3420-9 FAMOTIDINE 90 in 1 BOTTLE TABLET, FILM COATED 90 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-3420 FAMOTIDINE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] 5 Current NDC, 5 package rows 20240630_fd271deb-c748-bf26-e053-6294a90a11aa.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 2 of 2 · 22 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 68071-3420-3 68071342003 30 TABLET, FILM COATED in 1 BOTTLE (68071-3420-3) 2023-07-26 No No Current 68071-3420-6 68071342006 60 TABLET, FILM COATED in 1 BOTTLE (68071-3420-6) 2023-06-01 No No Current 68071-3420-7 68071342007 14 TABLET, FILM COATED in 1 BOTTLE (68071-3420-7) 2023-07-26 No No Current 68071-3420-8 68071342008 120 TABLET, FILM COATED in 1 BOTTLE (68071-3420-8) 2023-07-26 No No Current 68071-3420-9 68071342009 90 TABLET, FILM COATED in 1 BOTTLE (68071-3420-9) 2023-07-26 No No Current