FDA.reportPublic FDA data

Captopril

Product NDC
53808-0217
11-digit product format
538080217
Labeler code
53808
Product ID
53808-0217_769ec7f0-f2c0-4a40-89bb-c7c7776a1a37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Captopril
Dosage form
TABLET
Route
ORAL
Labeler
DOH CENTRAL PHARMACY
Application
ANDA074505
Marketing category
ANDA
Marketing start
2009-07-01
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
No
Listing certified through
2019-12-31
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
53808-0217-12020-01-31C16284748780-19d75b9d1-1f65-f424-e053-dadaa90a57ceCaptopril Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0217-1Captopril30 in 1 BLISTER PACKTABLET304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPTOPRILACTIVE INGREDIENT9G64RSX1XDCAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
CAPTOPRILACTIVE MOIETY9G64RSX1XDCAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TCAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0217CAPTOPRIL TABLET [DOH CENTRAL PHARMACY]4Legacy NDC, 1 package rows20170124_2120f554-a09b-464c-9b86-786dd9f112b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308962captopril 100 MG Oral TabletPSN2120f554-a09b-464c-9b86-786dd9f112b14
308964captopril 50 MG Oral TabletPSN2120f554-a09b-464c-9b86-786dd9f112b14
308962captopril 100 MG Oral TabletSCD2120f554-a09b-464c-9b86-786dd9f112b14
308964captopril 50 MG Oral TabletSCD2120f554-a09b-464c-9b86-786dd9f112b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0217-15380802170130 in 1 BLISTER PACKHistorical