Home NDC 50090-3574-1 Cimetidine
Product NDC 50090-3574
Requested package NDC 50090-3574-1
11-digit product format 500903574
Labeler code 50090
Product ID 50090-3574_f09197f2-eaf2-452c-9b3a-58c411fd5e52
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cimetidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA074246
Marketing category ANDA
Marketing start 1994-05-17
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 164 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 2026-02-19 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…2024-10-29 15:01 UTC 2024-10 A074246-001 CIMETIDINE 200MG TABLET / ORAL AB 1994-05-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074246-002 CIMETIDINE 300MG TABLET / ORAL AB 1994-05-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074246-003 CIMETIDINE 400MG TABLET / ORAL AB 1994-05-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074246-004 CIMETIDINE 800MG TABLET / ORAL AB RS 1994-05-17 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 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 400 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 197507 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-3574-0 Cimetidine 30 in 1 BOTTLE TABLET, FILM COATED 30 7 50090-3574-1 Cimetidine 60 in 1 BOTTLE TABLET, FILM COATED 60 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-3574 CIMETIDINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 7 Current NDC, Legacy NDC, 2 package rows 20250503_28fa98b3-6c78-4b7b-9a37-84c879dbf58a.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 50090-3574-1 50090357401 60 TABLET, FILM COATED in 1 BOTTLE (50090-3574-1) 2019-06-24 0000-00-00 No No Current