Home NDC 70518-4084 FAMOTIDINE
Product NDC 70518-4084
11-digit product format 705184084
Labeler code 70518
Product ID 70518-4084_5a08357a-796e-8520-e063-6294a90a9d08
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FAMOTIDINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA215630
Marketing category ANDA
Marketing start 2024-05-17
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 2027-12-31
Current FDA listing Yes 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 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70518-4084 70518-4084-0 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70518-4084 70518-4084-0 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FAMOTIDINE 40 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 284245 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 70518-4084-0 FAMOTIDINE 30 in 1 BLISTER PACK TABLET, FILM COATED 30 7 70518-4084-1 FAMOTIDINE 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 7 70518-4084-2 FAMOTIDINE 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-4084 FAMOTIDINE TABLET, FILM COATED [REMEDYREPACK INC.] 1 Current NDC, 3 package rows 20240522_9c5dce17-1865-4aa6-89f6-24dd55b5f06c.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 70518-4084-0 70518408400 30 in 1 BLISTER PACK Historical 70518-4084-1 70518408401 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4084-1) 2025-05-29 No No Current 70518-4084-2 70518408402 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4084-2) 2025-10-12 No No Current