heartburn prevention

Product NDC
59640-022
11-digit product format
596400022
Labeler code
59640
Product ID
59640-022_d578977f-3c3e-4a72-87bd-2f915938f146
Type
HUMAN OTC DRUG
Nonproprietary name
Cimetidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H E B
Application
ANDA075285
Marketing category
ANDA
Marketing start
2022-11-04
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 prevention
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
59640-022-72heartburn prevention1 in 1 CARTONTABLET, FILM COATED13
59640-022-72heartburn prevention60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59640-022HEARTBURN PREVENTION (CIMETIDINE) TABLET, FILM COATED [H E B]2Current NDC, Legacy NDC, 2 package rows20221118_f7156440-f2d8-4292-a436-388622ff3965.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197505cimetidine 200 MG Oral TabletPSNf7156440-f2d8-4292-a436-388622ff39653
197505cimetidine 200 MG Oral TabletSCDf7156440-f2d8-4292-a436-388622ff39653

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59640-022-72596400022721 BOTTLE in 1 CARTON (59640-022-72) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-11-040000-00-00NoNoCurrent