FDA.reportPublic FDA data

Cimetidine

Product NDC
68151-1742
11-digit product format
681511742
Labeler code
68151
Product ID
68151-1742_1fec3fc2-57a0-4ded-be7f-d19c7a3a6412
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cimetidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA074151
Marketing category
ANDA
Marketing start
2003-11-24
Marketing end
0000-00-00
Substance
CIMETIDINE
Active strength
300 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-1742-02020-01-31C16284748780-19d75b9d0-0853-f424-e053-dadaa90a57ceCIMETIDINE TABLETS USP 8192 8204 8305 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-1742-0Cimetidine1 in 1 PACKAGETABLET, FILM COATED14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIMETIDINEACTIVE INGREDIENT80061L1WGDCIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
CIMETIDINEACTIVE MOIETY80061L1WGDCIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMCIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-1742CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]4Legacy NDC, 1 package rows20170706_e35846d8-1647-46fa-b304-70f6fc7447e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197506cimetidine 300 MG Oral TabletPSNe35846d8-1647-46fa-b304-70f6fc7447e24
197506cimetidine 300 MG Oral TabletSCDe35846d8-1647-46fa-b304-70f6fc7447e24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-1742-0681511742001 in 1 PACKAGEHistorical