FDA.reportPublic FDA data

Cimetidine

Product NDC
0378-0053
11-digit product format
003780053
Labeler code
0378
Product ID
0378-0053_14717870-5f24-4002-ada5-1c5a44cc2be9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cimetidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA074246
Marketing category
ANDA
Marketing start
1994-05-17
Substance
CIMETIDINE
Active strength
200 mg/1
Pharmacologic classes
Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cimetidine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIMETIDINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80061L1WGD
Rxcui197505, 197506, 197507, 197508

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
0378-0053-01Cimetidine100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0053-01EA - Each0378-005311d24346-4105-46cf-9647-b80f4d75db2312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIMETIDINEACTIVE INGREDIENT80061L1WGDCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
CIMETIDINEACTIVE MOIETY80061L1WGDCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
POVIDONESINACTIVE INGREDIENTFZ989GH94ECIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
TRIACETININACTIVE INGREDIENTXHX3C3X673CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
VANILLININACTIVE INGREDIENTCHI530446XCIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]6
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
0378-0053CIMETIDINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 1 package rows20240113_06c0a509-026f-44e0-9975-a94a8de51d43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197505cimetidine 200 MG Oral TabletPSN06c0a509-026f-44e0-9975-a94a8de51d4311
197506cimetidine 300 MG Oral TabletPSN06c0a509-026f-44e0-9975-a94a8de51d4311
197507cimetidine 400 MG Oral TabletPSN06c0a509-026f-44e0-9975-a94a8de51d4311
197508cimetidine 800 MG Oral TabletPSN06c0a509-026f-44e0-9975-a94a8de51d4311
197505cimetidine 200 MG Oral TabletSCD06c0a509-026f-44e0-9975-a94a8de51d4311
197506cimetidine 300 MG Oral TabletSCD06c0a509-026f-44e0-9975-a94a8de51d4311
197507cimetidine 400 MG Oral TabletSCD06c0a509-026f-44e0-9975-a94a8de51d4311
197508cimetidine 800 MG Oral TabletSCD06c0a509-026f-44e0-9975-a94a8de51d4311
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0053-0100378005301100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0053-01) 1994-05-170000-00-00NoNoCurrent