Home NDC 69452-324-20 Cimetidine
Product NDC 69452-324
Requested package NDC 69452-324-20
11-digit product format 694520324
Labeler code 69452
Product ID 69452-324_2d7b7608-a2bd-dfde-e063-6294a90afa2c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cimetidine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bionpharma Inc.
Application ANDA218220
Marketing category ANDA
Marketing start 2025-03-01
Substance CIMETIDINE
Active strength 300 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 A218220-001 CIMETIDINE CIMETIDINE 200MG TABLET / ORAL AB 2024-11-07 A218220-002 CIMETIDINE CIMETIDINE 300MG TABLET / ORAL AB 2024-11-07 A218220-003 CIMETIDINE CIMETIDINE 400MG TABLET / ORAL AB 2024-11-07 A218220-004 CIMETIDINE CIMETIDINE 800MG TABLET / ORAL AB 2024-11-07
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.
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 2026-08-01 22:54:32 2026-06 A218220-001 CIMETIDINE 200MG TABLET / ORAL AB 2024-11-07 a50c72e98297…2026-08-01 22:54:32 2026-06 A218220-002 CIMETIDINE 300MG TABLET / ORAL AB 2024-11-07 a50c72e98297…2026-08-01 22:54:32 2026-06 A218220-003 CIMETIDINE 400MG TABLET / ORAL AB 2024-11-07 a50c72e98297…2026-08-01 22:54:32 2026-06 A218220-004 CIMETIDINE 800MG TABLET / ORAL AB 2024-11-07 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Cimetidine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CIMETIDINE 300 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 69452-324-20 Cimetidine 100 in 1 BOTTLE TABLET, FILM COATED 100 1 69452-324-30 Cimetidine 500 in 1 BOTTLE TABLET, FILM COATED 500 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-324 CIMETIDINE TABLET, FILM COATED [BIONPHARMA INC.] 1 Current NDC, 2 package rows 20250302_2d7b6e7d-cf01-70a2-e063-6394a90afbe6.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 69452-324-20 69452032420 100 TABLET, FILM COATED in 1 BOTTLE (69452-324-20) 2025-03-01 No No Current