FDA.reportPublic FDA data

Cimetidine

Product NDC
69452-325
11-digit product format
694520325
Labeler code
69452
Product ID
69452-325_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
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

Additional Listing Data#

Finished product
Yes
Brand name base
Cimetidine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIMETIDINE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80061L1WGD
Rxcui197505, 197506, 197507, 197508

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8f48ba86-02a3-4def-9efa-3a8140fd7adfProduct name220250624

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-325-20Cimetidine100 in 1 BOTTLETABLET, FILM COATED1001
69452-325-30Cimetidine500 in 1 BOTTLETABLET, FILM COATED5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-325-20EA - Each69452-325a181dc48-031b-4ce3-bdef-77634273fdd612025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-325CIMETIDINE TABLET, FILM COATED [BIONPHARMA INC.]1Current NDC, 2 package rows20250302_2d7b6e7d-cf01-70a2-e063-6394a90afbe6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197505cimetidine 200 MG Oral TabletPSN2d7b6e7d-cf01-70a2-e063-6394a90afbe61
197506cimetidine 300 MG Oral TabletPSN2d7b6e7d-cf01-70a2-e063-6394a90afbe61
197507cimetidine 400 MG Oral TabletPSN2d7b6e7d-cf01-70a2-e063-6394a90afbe61
197508cimetidine 800 MG Oral TabletPSN2d7b6e7d-cf01-70a2-e063-6394a90afbe61
197505cimetidine 200 MG Oral TabletSCD2d7b6e7d-cf01-70a2-e063-6394a90afbe61
197506cimetidine 300 MG Oral TabletSCD2d7b6e7d-cf01-70a2-e063-6394a90afbe61
197507cimetidine 400 MG Oral TabletSCD2d7b6e7d-cf01-70a2-e063-6394a90afbe61
197508cimetidine 800 MG Oral TabletSCD2d7b6e7d-cf01-70a2-e063-6394a90afbe61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69452-325-2069452032520100 TABLET, FILM COATED in 1 BOTTLE (69452-325-20) 2025-03-01NoNoCurrent
69452-325-3069452032530500 TABLET, FILM COATED in 1 BOTTLE (69452-325-30) 2025-03-01NoNoCurrent