Home NDC 33261-024 Cimetidine
Product NDC 33261-024
11-digit product format 332610024
Labeler code 33261
Product ID 33261-024_d122e35a-08d1-441b-8a9d-b9b99ddcab9e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cimetidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aidarex Pharmaceuticals LLC
Application ANDA074151
Marketing category ANDA
Marketing start 2004-02-02
Marketing end 0000-00-00
Substance CIMETIDINE
Active strength 400 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 1 · 42 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 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 33261-024-60 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 33261-024-60 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 33261-024-60 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 33261-024-60 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 33261-024-60 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 33261-024-60 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 33261-024-60 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 33261-024-60 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 33261-024-60 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 33261-024-60 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 33261-024-60 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 33261-024-60 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 33261-024-60 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 33261-024-60 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 33261-024-60 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 33261-024-60 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 33261-024-60 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 33261-024-60 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 33261-024-60 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 33261-024-60 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 33261-024-60 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 129 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 A074151-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074151-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074151-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 4 · 129 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 33261-024-60 Cimetidine 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CIMETIDINE ACTIVE INGREDIENT 80061L1WGD CIMETIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 CIMETIDINE ACTIVE MOIETY 80061L1WGD CIMETIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 CIMETIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ CIMETIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CIMETIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CIMETIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CIMETIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CIMETIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CIMETIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CIMETIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CIMETIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CIMETIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E CIMETIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CIMETIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CIMETIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CIMETIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U CIMETIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CIMETIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM CIMETIDINE 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 33261-024 CIMETIDINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 Legacy NDC, 1 package rows 20140102_615823a3-07ec-4469-83d9-ac4078c2c22e.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 33261-024-60 33261002460 60 in 1 BOTTLE, PLASTIC Historical