Home NDC 0093-8305-99 Cimetidine
Product NDC 0093-8305
Requested package NDC 0093-8305-99
11-digit product format 000938305
Labeler code 0093
Product ID 0093-8305_629411bd-d0df-467e-bab1-4fef95f9e46f
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 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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 A074463-001 CIMETIDINE 800MG TABLET / ORAL AB 1994-05-17 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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 Cimetidine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CIMETIDINE 800 mg/1
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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Status 0093-8305-99 00093830599 16484 TABLET, FILM COATED in 1 PAIL (0093-8305-99) 30-MAR-23 Current