Home NDC 69452-323 Cimetidine
Product NDC 69452-323
11-digit product format 694520323
Labeler code 69452
Product ID 69452-323_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 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 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 2026-08-18 06:07:40 2026-07 A218220-001 CIMETIDINE 200MG TABLET / ORAL AB 2024-11-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218220-002 CIMETIDINE 300MG TABLET / ORAL AB 2024-11-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218220-003 CIMETIDINE 400MG TABLET / ORAL AB 2024-11-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218220-004 CIMETIDINE 800MG TABLET / ORAL AB 2024-11-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218220-001 CIMETIDINE 200MG TABLET / ORAL AB 2024-11-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218220-002 CIMETIDINE 300MG TABLET / ORAL AB 2024-11-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218220-003 CIMETIDINE 400MG TABLET / ORAL AB 2024-11-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218220-004 CIMETIDINE 800MG TABLET / ORAL AB 2024-11-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218220-001 CIMETIDINE 200MG TABLET / ORAL AB 2024-11-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218220-002 CIMETIDINE 300MG TABLET / ORAL AB 2024-11-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218220-003 CIMETIDINE 400MG TABLET / ORAL AB 2024-11-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218220-004 CIMETIDINE 800MG TABLET / ORAL AB 2024-11-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218220-001 CIMETIDINE 200MG TABLET / ORAL AB 2024-11-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218220-002 CIMETIDINE 300MG TABLET / ORAL AB 2024-11-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218220-003 CIMETIDINE 400MG TABLET / ORAL AB 2024-11-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218220-004 CIMETIDINE 800MG TABLET / ORAL AB 2024-11-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218220-001 CIMETIDINE 200MG TABLET / ORAL AB 2024-11-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218220-002 CIMETIDINE 300MG TABLET / ORAL AB 2024-11-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218220-003 CIMETIDINE 400MG TABLET / ORAL AB 2024-11-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218220-004 CIMETIDINE 800MG TABLET / ORAL AB 2024-11-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218220-001 CIMETIDINE 200MG TABLET / ORAL AB 2024-11-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218220-002 CIMETIDINE 300MG TABLET / ORAL AB 2024-11-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218220-003 CIMETIDINE 400MG TABLET / ORAL AB 2024-11-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218220-004 CIMETIDINE 800MG TABLET / ORAL AB 2024-11-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218220-001 CIMETIDINE 200MG TABLET / ORAL AB 2024-11-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218220-002 CIMETIDINE 300MG TABLET / ORAL AB 2024-11-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218220-003 CIMETIDINE 400MG TABLET / ORAL AB 2024-11-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218220-004 CIMETIDINE 800MG TABLET / ORAL AB 2024-11-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218220-001 CIMETIDINE 200MG TABLET / ORAL AB 2024-11-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218220-002 CIMETIDINE 300MG TABLET / ORAL AB 2024-11-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218220-003 CIMETIDINE 400MG TABLET / ORAL AB 2024-11-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218220-004 CIMETIDINE 800MG TABLET / ORAL AB 2024-11-07 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218220-001 CIMETIDINE 200MG TABLET / ORAL AB 2024-11-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218220-002 CIMETIDINE 300MG TABLET / ORAL AB 2024-11-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218220-003 CIMETIDINE 400MG TABLET / ORAL AB 2024-11-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218220-004 CIMETIDINE 800MG TABLET / ORAL AB 2024-11-07 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Cimetidine
Listing expiration 2026-12-31 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 69452-323-20 Cimetidine 100 in 1 BOTTLE TABLET, FILM COATED 100 1 69452-323-30 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 69452-323 CIMETIDINE TABLET, FILM COATED [BIONPHARMA INC.] 1 Current NDC, 2 package rows 20250302_2d7b6e7d-cf01-70a2-e063-6394a90afbe6.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 Sample Exclude flag Status 69452-323-20 69452032320 100 TABLET, FILM COATED in 1 BOTTLE (69452-323-20) 2025-03-01 No No Current 69452-323-30 69452032330 500 TABLET, FILM COATED in 1 BOTTLE (69452-323-30) 2025-03-01 No No Current