Home NDC 63629-1783-2 Cimetidine
Product NDC 63629-1783
Requested package NDC 63629-1783-2
11-digit product format 636291783
Labeler code 63629
Product ID 63629-1783_da171b05-5996-40eb-8258-1b4291a976ac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cimetidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA074151
Marketing category ANDA
Marketing start 2003-11-24
Substance CIMETIDINE
Active strength 300 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 · 13 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074151-001 CIMETIDINE CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 A074151-002 CIMETIDINE CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 A074151-003 CIMETIDINE CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 126 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 2026-08-18 06:07:40 2026-07 A074151-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074151-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074151-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074151-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074151-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074151-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074151-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074151-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074151-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074151-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074151-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074151-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074151-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074151-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074151-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074151-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074151-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074151-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074151-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074151-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074151-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074151-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074151-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074151-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074151-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074151-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074151-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074151-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074151-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074151-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074151-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074151-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074151-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074151-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074151-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074151-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074151-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074151-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074151-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074151-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cimetidine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CIMETIDINE 300 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197506 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CIMETIDINE ACTIVE INGREDIENT 80061L1WGD CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 CIMETIDINE ACTIVE MOIETY 80061L1WGD CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 POVIDONES INACTIVE INGREDIENT FZ989GH94E CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 TALC INACTIVE INGREDIENT 7SEV7J4R1U CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000
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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 63629-1783-2 63629178302 60 TABLET, FILM COATED in 1 BOTTLE (63629-1783-2) 2005-01-19 0000-00-00 No No Current