FDA.reportPublic FDA data

Captopril

Product NDC
68645-163
11-digit product format
686450163
Labeler code
68645
Product ID
68645-163_20fd1a9b-ba61-4258-a38e-8d4f570f5831
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Captopril
Dosage form
TABLET
Route
ORAL
Labeler
Legacy Pharmaceutical Packaging
Application
ANDA074532
Marketing category
ANDA
Marketing start
2009-09-11
Marketing end
0000-00-00
Substance
CAPTOPRIL
Active strength
100 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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
68645-163-592020-01-31C16284748780-19d75b9d0-04f3-f424-e053-dadaa90a57ceCAPTOPRIL TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68645-163-59Captopril60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68645-163-59EA - Each68645-16366b3e416-2a08-46e7-a8ae-a812595e883412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPTOPRILACTIVE INGREDIENT9G64RSX1XDCAPTOPRIL TABLET [LEGACY PHARMACEUTICAL PACKAGING]2
CAPTOPRILACTIVE MOIETY9G64RSX1XDCAPTOPRIL TABLET [LEGACY PHARMACEUTICAL PACKAGING]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCAPTOPRIL TABLET [LEGACY PHARMACEUTICAL PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCAPTOPRIL TABLET [LEGACY PHARMACEUTICAL PACKAGING]2
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1CAPTOPRIL TABLET [LEGACY PHARMACEUTICAL PACKAGING]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAPTOPRIL TABLET [LEGACY PHARMACEUTICAL PACKAGING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCAPTOPRIL TABLET [LEGACY PHARMACEUTICAL PACKAGING]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCAPTOPRIL TABLET [LEGACY PHARMACEUTICAL PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68645-163CAPTOPRIL TABLET [LEGACY PHARMACEUTICAL PACKAGING]2Legacy NDC, 1 package rows20110511_af396e2c-198a-4082-a0a1-d4e673d32fec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308962captopril 100 MG Oral TabletPSNaf396e2c-198a-4082-a0a1-d4e673d32fec2
308963captopril 12.5 MG Oral TabletPSNaf396e2c-198a-4082-a0a1-d4e673d32fec2
317173captopril 25 MG Oral TabletPSNaf396e2c-198a-4082-a0a1-d4e673d32fec2
308964captopril 50 MG Oral TabletPSNaf396e2c-198a-4082-a0a1-d4e673d32fec2
308962captopril 100 MG Oral TabletSCDaf396e2c-198a-4082-a0a1-d4e673d32fec2
308963captopril 12.5 MG Oral TabletSCDaf396e2c-198a-4082-a0a1-d4e673d32fec2
317173captopril 25 MG Oral TabletSCDaf396e2c-198a-4082-a0a1-d4e673d32fec2
308964captopril 50 MG Oral TabletSCDaf396e2c-198a-4082-a0a1-d4e673d32fec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68645-163-596864501635960 in 1 BOTTLEHistorical