Home NDC 0378-0053 Cimetidine
Product NDC 0378-0053
11-digit product format 003780053
Labeler code 0378
Product ID 0378-0053_14717870-5f24-4002-ada5-1c5a44cc2be9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cimetidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA074246
Marketing category ANDA
Marketing start 1994-05-17
Substance CIMETIDINE
Active strength 200 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 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 A074246-001 CIMETIDINE CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 A074246-002 CIMETIDINE CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 A074246-003 CIMETIDINE CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 A074246-004 CIMETIDINE CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17
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.
Product history page 1 of 5 · 168 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 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 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 200 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 0378-0053-01 Cimetidine 100 in 1 BOTTLE, PLASTIC 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 [MYLAN PHARMACEUTICALS INC.] 6 CIMETIDINE ACTIVE MOIETY 80061L1WGD CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 POVIDONES INACTIVE INGREDIENT FZ989GH94E CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 SODIUM ALGINATE INACTIVE INGREDIENT C269C4G2ZQ CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 VANILLIN INACTIVE INGREDIENT CHI530446X CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 6 CIMETIDINE ACTIVE INGREDIENT 80061L1WGD CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 CIMETIDINE ACTIVE MOIETY 80061L1WGD CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 SODIUM ALGINATE INACTIVE INGREDIENT C269C4G2ZQ CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2 VANILLIN INACTIVE INGREDIENT CHI530446X CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-0053 CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 Current NDC, Legacy NDC, 1 package rows 20240113_06c0a509-026f-44e0-9975-a94a8de51d43.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 · 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 0378-0053-01 00378005301 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0053-01) 1994-05-17 0000-00-00 No No Current