Home NDC 59651-826 CIMETIDINE
Product NDC 59651-826
11-digit product format 596510826
Labeler code 59651
Product ID 59651-826_ebd53065-c080-4045-a398-64d3f3b1460f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CIMETIDINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA218997
Marketing category ANDA
Marketing start 2024-11-12
Substance CIMETIDINE
Active strength 800 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 NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 59651-826 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 59651-826 59651-826-55 UNFINISHED Active or certified unfinished drug listing 2026-08-17
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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 59651-826-55 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 59651-826-55 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 59651-826-55 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 59651-826-55 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 59651-826-55 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 59651-826-55 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 59651-826-55 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 59651-826-55 68b1e3bced9e…98a755eb8bc6…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218997-001 CIMETIDINE CIMETIDINE 200MG TABLET / ORAL AB 2024-11-12 A218997-002 CIMETIDINE CIMETIDINE 300MG TABLET / ORAL AB 2024-11-12 A218997-003 CIMETIDINE CIMETIDINE 400MG TABLET / ORAL AB 2024-11-12 A218997-004 CIMETIDINE CIMETIDINE 800MG TABLET / ORAL AB 2024-11-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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.
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 2026-08-18 06:07:40 2026-07 A218997-001 CIMETIDINE 200MG TABLET / ORAL AB 2024-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218997-002 CIMETIDINE 300MG TABLET / ORAL AB 2024-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218997-003 CIMETIDINE 400MG TABLET / ORAL AB 2024-11-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218997-004 CIMETIDINE 800MG TABLET / ORAL AB 2024-11-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218997-001 CIMETIDINE 200MG TABLET / ORAL AB 2024-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218997-002 CIMETIDINE 300MG TABLET / ORAL AB 2024-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218997-003 CIMETIDINE 400MG TABLET / ORAL AB 2024-11-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218997-004 CIMETIDINE 800MG TABLET / ORAL AB 2024-11-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218997-001 CIMETIDINE 200MG TABLET / ORAL AB 2024-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218997-002 CIMETIDINE 300MG TABLET / ORAL AB 2024-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218997-003 CIMETIDINE 400MG TABLET / ORAL AB 2024-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218997-004 CIMETIDINE 800MG TABLET / ORAL AB 2024-11-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218997-001 CIMETIDINE 200MG TABLET / ORAL AB 2024-11-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218997-002 CIMETIDINE 300MG TABLET / ORAL AB 2024-11-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218997-003 CIMETIDINE 400MG TABLET / ORAL AB 2024-11-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218997-004 CIMETIDINE 800MG TABLET / ORAL AB 2024-11-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218997-001 CIMETIDINE 200MG TABLET / ORAL AB 2024-11-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218997-002 CIMETIDINE 300MG TABLET / ORAL AB 2024-11-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218997-003 CIMETIDINE 400MG TABLET / ORAL AB 2024-11-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218997-004 CIMETIDINE 800MG TABLET / ORAL AB 2024-11-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218997-001 CIMETIDINE 200MG TABLET / ORAL AB 2024-11-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218997-002 CIMETIDINE 300MG TABLET / ORAL AB 2024-11-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218997-003 CIMETIDINE 400MG TABLET / ORAL AB 2024-11-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218997-004 CIMETIDINE 800MG TABLET / ORAL AB 2024-11-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218997-001 CIMETIDINE 200MG TABLET / ORAL AB 2024-11-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218997-002 CIMETIDINE 300MG TABLET / ORAL AB 2024-11-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218997-003 CIMETIDINE 400MG TABLET / ORAL AB 2024-11-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218997-004 CIMETIDINE 800MG TABLET / ORAL AB 2024-11-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218997-001 CIMETIDINE 200MG TABLET / ORAL AB 2024-11-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218997-002 CIMETIDINE 300MG TABLET / ORAL AB 2024-11-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218997-003 CIMETIDINE 400MG TABLET / ORAL AB 2024-11-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218997-004 CIMETIDINE 800MG TABLET / ORAL AB 2024-11-12 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218997-001 CIMETIDINE 200MG TABLET / ORAL AB 2024-11-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218997-002 CIMETIDINE 300MG TABLET / ORAL AB 2024-11-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218997-003 CIMETIDINE 400MG TABLET / ORAL AB 2024-11-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218997-004 CIMETIDINE 800MG TABLET / ORAL AB 2024-11-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base CIMETIDINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CIMETIDINE 800 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 80061L1WGD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197505 Internal RxNorm lookup 197506 Internal RxNorm lookup 197507 Internal RxNorm lookup 197508 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 59651-826-01 CIMETIDINE 100 in 1 BOTTLE TABLET, FILM COATED 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-826 CIMETIDINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 1 Current NDC, 1 package rows 20241122_ebd53065-c080-4045-a398-64d3f3b1460f.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 Marketing start Sample Exclude flag Status 59651-826-01 59651082601 100 TABLET, FILM COATED in 1 BOTTLE (59651-826-01) 2024-11-12 No No Current 59651-826-55 59651082655 15000 TABLET, FILM COATED in 1 BAG (59651-826-55) 12-NOV-24 Current