FDA.reportPublic FDA data

CAPTOPRIL

Product NDC
64679-904
11-digit product format
646790904
Labeler code
64679
Product ID
64679-904_7497d288-2502-4623-8bb8-17c6e20cc6f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
captopril
Dosage form
TABLET
Route
ORAL
Labeler
Wockhardt USA LLC.
Application
ANDA074532
Marketing category
ANDA
Marketing start
1997-03-28
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
2021-12-31
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
64679-904-012025-12-19C16284748780-1c7ccaba7-0ef7-fd44-e053-dadaa90aa01b4a3e016f-8c88-4041-9a56-0090b0cd170a
64679-904-022025-12-19C16284748780-1c7ccaba7-0ef7-fd44-e053-dadaa90aa01b4a3e016f-8c88-4041-9a56-0090b0cd170a
64679-904-052025-12-19C16284748780-1c7ccaba7-0ef7-fd44-e053-dadaa90aa01b4a3e016f-8c88-4041-9a56-0090b0cd170a
64679-904-012021-07-23C16284748780-1c7ccaba7-0ef7-fd44-e053-dadaa90aa01b4a3e016f-8c88-4041-9a56-0090b0cd170a
64679-904-022021-07-23C16284748780-1c7ccaba7-0ef7-fd44-e053-dadaa90aa01b4a3e016f-8c88-4041-9a56-0090b0cd170a
64679-904-052021-07-23C16284748780-1c7ccaba7-0ef7-fd44-e053-dadaa90aa01b4a3e016f-8c88-4041-9a56-0090b0cd170a

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-904-01EA - Each64679-904b42c301a-3910-49c8-bd9b-14b2a14b7f7312012-07-24
64679-904-02EA - Each64679-904959dbd71-994f-4fc4-8ca5-1376cfb98c4b12012-07-24
64679-904-05EA - Each64679-90437aee0eb-1720-45cb-a766-0cf52411d6c512015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPTOPRILACTIVE INGREDIENT9G64RSX1XDCAPTOPRIL TABLET [BLENHEIM PHARMACAL, INC.]5
CAPTOPRILACTIVE MOIETY9G64RSX1XDCAPTOPRIL TABLET [BLENHEIM PHARMACAL, INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCAPTOPRIL TABLET [BLENHEIM PHARMACAL, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCAPTOPRIL TABLET [BLENHEIM PHARMACAL, INC.]5
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1CAPTOPRIL TABLET [BLENHEIM PHARMACAL, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAPTOPRIL TABLET [BLENHEIM PHARMACAL, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCAPTOPRIL TABLET [BLENHEIM PHARMACAL, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UCAPTOPRIL TABLET [BLENHEIM PHARMACAL, INC.]5
CAPTOPRILACTIVE INGREDIENT9G64RSX1XDCAPTOPRIL TABLET CAPTOPRIL (CAPTORPIL) TABLET [WOCKHARDT USA LLC.]3
CAPTOPRILACTIVE INGREDIENT9G64RSX1XDCAPTOPRIL TABLET [GLENVIEW PHARMA INC.]3
CAPTOPRILACTIVE MOIETY9G64RSX1XDCAPTOPRIL TABLET CAPTOPRIL (CAPTORPIL) TABLET [WOCKHARDT USA LLC.]3
CAPTOPRILACTIVE MOIETY9G64RSX1XDCAPTOPRIL TABLET [GLENVIEW PHARMA INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCAPTOPRIL TABLET CAPTOPRIL (CAPTORPIL) TABLET [WOCKHARDT USA LLC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCAPTOPRIL TABLET [GLENVIEW PHARMA INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCAPTOPRIL TABLET CAPTOPRIL (CAPTORPIL) TABLET [WOCKHARDT USA LLC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCAPTOPRIL TABLET [GLENVIEW PHARMA INC.]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAPTOPRIL TABLET [GLENVIEW PHARMA INC.]3
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1CAPTOPRIL TABLET CAPTOPRIL (CAPTORPIL) TABLET [WOCKHARDT USA LLC.]3
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1CAPTOPRIL TABLET [GLENVIEW PHARMA INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAPTOPRIL TABLET CAPTOPRIL (CAPTORPIL) TABLET [WOCKHARDT USA LLC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCAPTOPRIL TABLET CAPTOPRIL (CAPTORPIL) TABLET [WOCKHARDT USA LLC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCAPTOPRIL TABLET [GLENVIEW PHARMA INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UCAPTOPRIL TABLET CAPTOPRIL (CAPTORPIL) TABLET [WOCKHARDT USA LLC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UCAPTOPRIL TABLET [GLENVIEW PHARMA INC.]3
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
CAPTOPRILACTIVE INGREDIENT9G64RSX1XDCAPTOPRIL (CAPTORPIL) TABLET [REBEL DISTRIBUTORS CORP]1
CAPTOPRILACTIVE INGREDIENT9G64RSX1XDCAPTOPRIL (CAPTORPIL) TABLET [AIDAREX PHARMACEUTICALS LLC]1
CAPTOPRILACTIVE INGREDIENT9G64RSX1XDCAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CAPTOPRILACTIVE MOIETY9G64RSX1XDCAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CAPTOPRILACTIVE MOIETY9G64RSX1XDCAPTOPRIL (CAPTORPIL) TABLET [AIDAREX PHARMACEUTICALS LLC]1
CAPTOPRILACTIVE MOIETY9G64RSX1XDCAPTOPRIL (CAPTORPIL) TABLET [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCAPTOPRIL (CAPTORPIL) TABLET [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCAPTOPRIL (CAPTORPIL) TABLET [AIDAREX PHARMACEUTICALS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCAPTOPRIL (CAPTORPIL) TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCAPTOPRIL (CAPTORPIL) TABLET [AIDAREX PHARMACEUTICALS LLC]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1CAPTOPRIL (CAPTORPIL) TABLET [REBEL DISTRIBUTORS CORP]1
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1CAPTOPRIL (CAPTORPIL) TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAPTOPRIL (CAPTORPIL) TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAPTOPRIL (CAPTORPIL) TABLET [REBEL DISTRIBUTORS CORP]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, CORNINACTIVE INGREDIENTO8232NY3SJCAPTOPRIL (CAPTORPIL) TABLET [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCAPTOPRIL (CAPTORPIL) TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TCAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCAPTOPRIL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCAPTOPRIL (CAPTORPIL) TABLET [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCAPTOPRIL (CAPTORPIL) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64679-904CAPTOPRIL TABLET [WOCKHARDT USA LLC.]8Legacy NDC20200117_4a3e016f-8c88-4041-9a56-0090b0cd170a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308964captopril 50 MG Oral TabletPSNbbec074e-04b1-4249-bf3b-85ee8b06c78a5
308964captopril 50 MG Oral TabletSCDbbec074e-04b1-4249-bf3b-85ee8b06c78a5
308963captopril 12.5 MG Oral TabletPSN8c6678fe-0da2-4f20-bacf-321e37e5799d3
317173captopril 25 MG Oral TabletPSN8c6678fe-0da2-4f20-bacf-321e37e5799d3
308964captopril 50 MG Oral TabletPSN8c6678fe-0da2-4f20-bacf-321e37e5799d3
308963captopril 12.5 MG Oral TabletSCD8c6678fe-0da2-4f20-bacf-321e37e5799d3
317173captopril 25 MG Oral TabletSCD8c6678fe-0da2-4f20-bacf-321e37e5799d3
308964captopril 50 MG Oral TabletSCD8c6678fe-0da2-4f20-bacf-321e37e5799d3
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
308962captopril 100 MG Oral TabletPSN6aeec5ee-94f1-4db3-92bf-7286900bea041
308962captopril 100 MG Oral TabletPSNa7b85288-9099-4c20-beb7-ee2be484c9b91
317173captopril 25 MG Oral TabletPSN6aeec5ee-94f1-4db3-92bf-7286900bea041
317173captopril 25 MG Oral TabletPSNa7b85288-9099-4c20-beb7-ee2be484c9b91
317173captopril 25 MG Oral TabletPSN851ff660-e6a4-48f8-a6d0-4c10dbb018361
308964captopril 50 MG Oral TabletPSNa7b85288-9099-4c20-beb7-ee2be484c9b91
308964captopril 50 MG Oral TabletPSN6aeec5ee-94f1-4db3-92bf-7286900bea041
308964captopril 50 MG Oral TabletPSN851ff660-e6a4-48f8-a6d0-4c10dbb018361
308962captopril 100 MG Oral TabletSCDa7b85288-9099-4c20-beb7-ee2be484c9b91
308962captopril 100 MG Oral TabletSCD6aeec5ee-94f1-4db3-92bf-7286900bea041
317173captopril 25 MG Oral TabletSCDa7b85288-9099-4c20-beb7-ee2be484c9b91
317173captopril 25 MG Oral TabletSCD851ff660-e6a4-48f8-a6d0-4c10dbb018361
317173captopril 25 MG Oral TabletSCD6aeec5ee-94f1-4db3-92bf-7286900bea041
308964captopril 50 MG Oral TabletSCDa7b85288-9099-4c20-beb7-ee2be484c9b91
308964captopril 50 MG Oral TabletSCD851ff660-e6a4-48f8-a6d0-4c10dbb018361
308964captopril 50 MG Oral TabletSCD6aeec5ee-94f1-4db3-92bf-7286900bea041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64679-904-0164679090401100 TABLET in 1 BOTTLE (64679-904-01) 100 tablet1997-03-280000-00-00NoNoCurrent
64679-904-02646790904021000 TABLET in 1 BOTTLE (64679-904-02) 1000 tablet1997-03-280000-00-00NoNoCurrent
64679-904-05646790904055000 TABLET in 1 POUCH (64679-904-05) 5000 tablet1997-03-280000-00-00NoNoCurrent