Cimetidine

Product NDC
51655-697
11-digit product format
516550697
Labeler code
51655
Product ID
51655-697_4950cd76-c47b-d0cf-e063-6394a90acf6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cimetidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA074246
Marketing category
ANDA
Marketing start
2021-04-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cimetidine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIMETIDINE400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80061L1WGD
Rxcui197507

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
51655-697-51Cimetidine40 in 1 BOTTLE, PLASTICTABLET, FILM COATED404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-697CIMETIDINE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 1 package rows20241228_db482bd8-e68d-3a38-e053-2995a90a38a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197507cimetidine 400 MG Oral TabletPSNdb482bd8-e68d-3a38-e053-2995a90a38a54
197507cimetidine 400 MG Oral TabletSCDdb482bd8-e68d-3a38-e053-2995a90a38a54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-697-515165506975140 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-697-51) 2021-04-01NoNoHistorical