FDA.reportPublic FDA data

Cimetidine

Product NDC
68151-1497
11-digit product format
681511497
Labeler code
68151
Product ID
68151-1497_75dc9419-1177-4afd-bbc1-f168cf6fa25e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cimetidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA074246
Marketing category
ANDA
Marketing start
1994-05-17
Marketing end
0000-00-00
Substance
CIMETIDINE
Active strength
200 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
68151-1497-02020-01-31C16284748780-19d75b9d0-4723-f424-e053-dadaa90a57cea147850e-f881-4f9b-bf37-1b9e8cdf4020

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-1497-0Cimetidine1 in 1 PACKAGETABLET, FILM COATED12

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
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCIMETIDINE 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
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQCIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TRIACETININACTIVE INGREDIENTXHX3C3X673CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
VANILLININACTIVE INGREDIENTCHI530446XCIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-1497CIMETIDINE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20140707_a147850e-f881-4f9b-bf37-1b9e8cdf4020.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197505cimetidine 200 MG Oral TabletPSNa147850e-f881-4f9b-bf37-1b9e8cdf40202
197505cimetidine 200 MG Oral TabletSCDa147850e-f881-4f9b-bf37-1b9e8cdf40202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-1497-0681511497001 in 1 PACKAGEHistorical