Home NDC 0093-8305 Cimetidine
Product NDC 0093-8305
11-digit product format 000938305
Labeler code 0093
Product ID 0093-8305_e1f40596-aa5b-46a4-b2aa-add1150ac3a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cimetidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA074463
Marketing category ANDA
Marketing start 2003-12-06
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 0093-8305 UNFINISHED Active or certified unfinished drug listing 2026-08-17 unfinished package package 0093-8305 0093-8305-99 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 · 28 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 0093-8305-99 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 0093-8305-99 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 0093-8305-99 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 0093-8305-99 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 0093-8305-99 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 0093-8305-99 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 0093-8305-99 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 0093-8305-99 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 0093-8305-99 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 0093-8305-99 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 0093-8305-99 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 0093-8305-99 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 0093-8305-99 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 0093-8305-99 50b4072663b7…eae3003ed65e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074463-001 CIMETIDINE CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074463-001 AB
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 · 42 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 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 0093-8305-01 Cimetidine 100 in 1 BOTTLE TABLET, FILM COATED 100 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CIMETIDINE ACTIVE INGREDIENT 80061L1WGD CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 CIMETIDINE ACTIVE MOIETY 80061L1WGD CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 POVIDONE K25 INACTIVE INGREDIENT K0KQV10C35 CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 POVIDONE K26/28 INACTIVE INGREDIENT H7AGY1OJO8 CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-8305 CIMETIDINE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] 11 Current NDC, Legacy NDC, 1 package rows 20230717_496e258d-a5fd-42da-9a86-73afc8be359b.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 Marketing end Sample Exclude flag Status 0093-8305-01 00093830501 100 TABLET, FILM COATED in 1 BOTTLE (0093-8305-01) 2003-12-23 0000-00-00 No No Current 0093-8305-99 00093830599 16484 TABLET, FILM COATED in 1 PAIL (0093-8305-99) 30-MAR-23 Current