Captopril

Product NDC
53808-0912
11-digit product format
538080912
Labeler code
53808
Product ID
53808-0912_e4a7f215-ee57-4a42-9cc8-8656a08f45ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Captopril
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida 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
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
53808-0912-12019-10-21C16284748780-1956f9ecf-d2c3-621f-e053-dbdaa90a74adCaptopril Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0912-1Captopril30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPTOPRILACTIVE INGREDIENT9G64RSX1XDCAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CAPTOPRILACTIVE MOIETY9G64RSX1XDCAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TCAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0912CAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100805_a7b85288-9099-4c20-beb7-ee2be484c9b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308962captopril 100 MG Oral TabletPSNa7b85288-9099-4c20-beb7-ee2be484c9b91
317173captopril 25 MG Oral TabletPSNa7b85288-9099-4c20-beb7-ee2be484c9b91
308964captopril 50 MG Oral TabletPSNa7b85288-9099-4c20-beb7-ee2be484c9b91
308962captopril 100 MG Oral TabletSCDa7b85288-9099-4c20-beb7-ee2be484c9b91
317173captopril 25 MG Oral TabletSCDa7b85288-9099-4c20-beb7-ee2be484c9b91
308964captopril 50 MG Oral TabletSCDa7b85288-9099-4c20-beb7-ee2be484c9b91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0912-15380809120130 in 1 BLISTER PACKHistorical