Cimetidine

Product NDC
63629-1783
11-digit product format
636291783
Labeler code
63629
Product ID
63629-1783_da171b05-5996-40eb-8258-1b4291a976ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cimetidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074151
Marketing category
ANDA
Marketing start
2003-11-24
Substance
CIMETIDINE
Active strength
300 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
CIMETIDINE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80061L1WGD
Rxcui197506

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
63629-1783-12020-10-16C16284748780-19d75b9d0-f39a-f424-e053-dadaa90a57ceCIMETIDINE TABLETS USP 8192 8204 8305 Rx only
63629-1783-22020-10-16C16284748780-19d75b9d0-f39a-f424-e053-dadaa90a57ceCIMETIDINE TABLETS USP 8192 8204 8305 Rx only
63629-1783-32020-10-16C16284748780-19d75b9d0-f39a-f424-e053-dadaa90a57ceCIMETIDINE TABLETS USP 8192 8204 8305 Rx only
63629-1783-42020-10-16C16284748780-19d75b9d0-f39a-f424-e053-dadaa90a57ceCIMETIDINE TABLETS USP 8192 8204 8305 Rx only
63629-1783-52020-10-16C16284748780-19d75b9d0-f39a-f424-e053-dadaa90a57ceCIMETIDINE TABLETS USP 8192 8204 8305 Rx only
63629-1783-62020-10-16C16284748780-19d75b9d0-f39a-f424-e053-dadaa90a57ceCIMETIDINE TABLETS USP 8192 8204 8305 Rx only
63629-1783-72020-10-16C16284748780-19d75b9d0-f39a-f424-e053-dadaa90a57ceCIMETIDINE TABLETS USP 8192 8204 8305 Rx only
63629-1783-12020-01-31C16284748780-19d75b9d0-f39a-f424-e053-dadaa90a57ceCIMETIDINE TABLETS USP 8192 8204 8305 Rx only
63629-1783-22020-01-31C16284748780-19d75b9d0-f39a-f424-e053-dadaa90a57ceCIMETIDINE TABLETS USP 8192 8204 8305 Rx only
63629-1783-32020-01-31C16284748780-19d75b9d0-f39a-f424-e053-dadaa90a57ceCIMETIDINE TABLETS USP 8192 8204 8305 Rx only
63629-1783-42020-01-31C16284748780-19d75b9d0-f39a-f424-e053-dadaa90a57ceCIMETIDINE TABLETS USP 8192 8204 8305 Rx only
63629-1783-52020-01-31C16284748780-19d75b9d0-f39a-f424-e053-dadaa90a57ceCIMETIDINE TABLETS USP 8192 8204 8305 Rx only
63629-1783-62020-01-31C16284748780-19d75b9d0-f39a-f424-e053-dadaa90a57ceCIMETIDINE TABLETS USP 8192 8204 8305 Rx only
63629-1783-72020-01-31C16284748780-19d75b9d0-f39a-f424-e053-dadaa90a57ceCIMETIDINE TABLETS USP 8192 8204 8305 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1783-1Cimetidine30 in 1 BOTTLETABLET, FILM COATED301008
63629-1783-2Cimetidine60 in 1 BOTTLETABLET, FILM COATED601008
63629-1783-3Cimetidine20 in 1 BOTTLETABLET, FILM COATED201008
63629-1783-4Cimetidine21 in 1 BOTTLETABLET, FILM COATED211008
63629-1783-5Cimetidine90 in 1 BOTTLETABLET, FILM COATED901008
63629-1783-6Cimetidine120 in 1 BOTTLETABLET, FILM COATED1201008
63629-1783-7Cimetidine28 in 1 BOTTLETABLET, FILM COATED281008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1783-1EA - Each63629-178323ac4f88-876c-426d-915c-4a3747071e3c12013-02-13
63629-1783-2EA - Each63629-17834ae019bb-d2e9-48cd-9054-ff4676005a4a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIMETIDINEACTIVE INGREDIENT80061L1WGDCIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CIMETIDINEACTIVE MOIETY80061L1WGDCIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POVIDONESINACTIVE INGREDIENTFZ989GH94ECIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1UCIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMCIMETIDINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197506cimetidine 300 MG Oral TabletPSN0ab5ea2b-bd2f-49ec-9e92-033bed9987971008
197506cimetidine 300 MG Oral TabletSCD0ab5ea2b-bd2f-49ec-9e92-033bed9987971008

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1783-16362917830130 TABLET, FILM COATED in 1 BOTTLE (63629-1783-1) 2005-01-190000-00-00NoNoCurrent
63629-1783-26362917830260 TABLET, FILM COATED in 1 BOTTLE (63629-1783-2) 2005-01-190000-00-00NoNoCurrent
63629-1783-36362917830320 TABLET, FILM COATED in 1 BOTTLE (63629-1783-3) 2005-01-190000-00-00NoNoCurrent
63629-1783-46362917830421 TABLET, FILM COATED in 1 BOTTLE (63629-1783-4) 2005-01-190000-00-00NoNoCurrent
63629-1783-56362917830590 TABLET, FILM COATED in 1 BOTTLE (63629-1783-5) 2005-01-190000-00-00NoNoCurrent
63629-1783-663629178306120 TABLET, FILM COATED in 1 BOTTLE (63629-1783-6) 2005-01-190000-00-00NoNoCurrent
63629-1783-76362917830728 TABLET, FILM COATED in 1 BOTTLE (63629-1783-7) 2005-01-190000-00-00NoNoCurrent