FDA.reportPublic FDA data

Cimetidine

Product NDC
10544-627
11-digit product format
105440627
Labeler code
10544
Product ID
10544-627_105668c7-5439-63fc-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cimetidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA074151
Marketing category
ANDA
Marketing start
2014-01-14
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
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8f48ba86-02a3-4def-9efa-3a8140fd7adfProduct name220250624
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-627-302020-01-31C16284748780-19d75b9d0-86d4-f424-e053-dadaa90a57ceCIMETIDINE TABLETS USP 8192 8204 8305 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-627-30Cimetidine30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-627-30EA - Each10544-62741d9689f-e1f6-41cd-baae-6de39a08f8c912015-04-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-627CIMETIDINE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 1 package rows20150303_0fb333e0-5169-5f7a-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197506cimetidine 300 MG Oral TabletPSN0fb333e0-5169-5f7a-e054-00144ff88e882
197507cimetidine 400 MG Oral TabletPSN0fb333e0-5169-5f7a-e054-00144ff88e882
197506cimetidine 300 MG Oral TabletSCD0fb333e0-5169-5f7a-e054-00144ff88e882
197507cimetidine 400 MG Oral TabletSCD0fb333e0-5169-5f7a-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-627-301054406273030 in 1 BOTTLEHistorical