Captopril

Product NDC
21695-478
11-digit product format
216950478
Labeler code
21695
Product ID
21695-478_1893cb9f-bdae-4e17-ac6d-8bef66010d7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Captopril
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA074505
Marketing category
ANDA
Marketing start
1996-02-13
Marketing end
0000-00-00
Substance
CAPTOPRIL
Active strength
50 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
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
d5efca61-58ec-b4d0-77f8-f2b1fb112156Product name420240223

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-478-302019-09-24C16284748780-1934fe258-4c98-48b1-e053-8cdaa90a720aCaptopril Tablets, USP Rev. 11/08 Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-478-30Captopril30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-478-30EA - Each21695-47879a5ea52-c5b6-4adb-92a0-791b46f95be812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPTOPRILACTIVE INGREDIENT9G64RSX1XDCAPTOPRIL TABLET [REBEL DISTRIBUTORS CORP]1
CAPTOPRILACTIVE MOIETY9G64RSX1XDCAPTOPRIL TABLET [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCAPTOPRIL TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCAPTOPRIL TABLET [REBEL DISTRIBUTORS CORP]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAPTOPRIL TABLET [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CAPTOPRIL TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCAPTOPRIL TABLET [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCAPTOPRIL TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-478CAPTOPRIL TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101220_1893cb9f-bdae-4e17-ac6d-8bef66010d7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317173captopril 25 MG Oral TabletPSN1893cb9f-bdae-4e17-ac6d-8bef66010d7a1
308964captopril 50 MG Oral TabletPSN1893cb9f-bdae-4e17-ac6d-8bef66010d7a1
317173captopril 25 MG Oral TabletSCD1893cb9f-bdae-4e17-ac6d-8bef66010d7a1
308964captopril 50 MG Oral TabletSCD1893cb9f-bdae-4e17-ac6d-8bef66010d7a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-478-302169504783030 in 1 BOTTLEHistorical