FDA.reportPublic FDA data

heartburn relief

Product NDC
59779-022
11-digit product format
597790022
Labeler code
59779
Product ID
59779-022_eb2f24b7-1a12-449e-9992-f10b2e3c7e4f
Type
HUMAN OTC DRUG
Nonproprietary name
Cimetidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA075285
Marketing category
ANDA
Marketing start
2009-08-07
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
heartburn relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIMETIDINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80061L1WGD
Rxcui197505

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
59779-022-72heartburn relief60 in 1 BOTTLETABLET, FILM COATED606
59779-022-72heartburn relief1 in 1 CARTONTABLET, FILM COATED16
59779-022-76heartburn relief120 in 1 BOTTLETABLET, FILM COATED1206
59779-022-76heartburn relief1 in 1 CARTONTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-022-72EA - Each59779-022348e825e-7aab-47e0-8670-056e4efb524612021-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIMETIDINEACTIVE INGREDIENT80061L1WGDHEARTBURN RELIEF (CIMETIDINE) TABLET [CVS PHARMACY]2
CIMETIDINEACTIVE MOIETY80061L1WGDHEARTBURN RELIEF (CIMETIDINE) TABLET [CVS PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHEARTBURN RELIEF (CIMETIDINE) TABLET [CVS PHARMACY]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHEARTBURN RELIEF (CIMETIDINE) TABLET [CVS PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HEARTBURN RELIEF (CIMETIDINE) TABLET [CVS PHARMACY]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AHEARTBURN RELIEF (CIMETIDINE) TABLET [CVS PHARMACY]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHEARTBURN RELIEF (CIMETIDINE) TABLET [CVS PHARMACY]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EHEARTBURN RELIEF (CIMETIDINE) TABLET [CVS PHARMACY]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHEARTBURN RELIEF (CIMETIDINE) TABLET [CVS PHARMACY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHEARTBURN RELIEF (CIMETIDINE) TABLET [CVS PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHEARTBURN RELIEF (CIMETIDINE) TABLET [CVS PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-022HEARTBURN RELIEF (CIMETIDINE) TABLET, FILM COATED [CVS PHARMACY]6Current NDC, Legacy NDC, 4 package rows20220121_464b1dec-3220-471c-b067-a06a87fb8cae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197505cimetidine 200 MG Oral TabletPSN464b1dec-3220-471c-b067-a06a87fb8cae6
197505cimetidine 200 MG Oral TabletSCD464b1dec-3220-471c-b067-a06a87fb8cae6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-022-72597790022721 BOTTLE in 1 CARTON (59779-022-72) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-08-070000-00-00NoNoCurrent
59779-022-76597790022761 BOTTLE in 1 CARTON (59779-022-76) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-01-050000-00-00NoNoCurrent