CAPTOPRIL

Product NDC
64679-902
11-digit product format
646790902
Labeler code
64679
Product ID
64679-902_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
13 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-902-01EA - Each64679-902bd22783e-c762-4311-b06e-309d25b74b0212012-07-24
64679-902-02EA - Each64679-9029e3eec1a-63f0-4411-a2b2-56eda7be6ee312012-07-24
64679-902-05EA - Each64679-902e7ea3d7c-d0f7-4383-bde6-9ccb560d466012015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPTOPRILACTIVE INGREDIENT9G64RSX1XDCAPTOPRIL TABLET [GLENVIEW PHARMA INC.]3
CAPTOPRILACTIVE INGREDIENT9G64RSX1XDCAPTOPRIL TABLET CAPTOPRIL (CAPTORPIL) TABLET [WOCKHARDT USA LLC.]3
CAPTOPRILACTIVE MOIETY9G64RSX1XDCAPTOPRIL TABLET [GLENVIEW PHARMA INC.]3
CAPTOPRILACTIVE MOIETY9G64RSX1XDCAPTOPRIL TABLET CAPTOPRIL (CAPTORPIL) TABLET [WOCKHARDT USA LLC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCAPTOPRIL TABLET [GLENVIEW PHARMA INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCAPTOPRIL TABLET CAPTOPRIL (CAPTORPIL) TABLET [WOCKHARDT USA LLC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCAPTOPRIL TABLET [GLENVIEW PHARMA INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCAPTOPRIL TABLET CAPTOPRIL (CAPTORPIL) TABLET [WOCKHARDT USA LLC.]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAPTOPRIL TABLET [GLENVIEW PHARMA INC.]3
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1CAPTOPRIL TABLET [GLENVIEW PHARMA INC.]3
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1CAPTOPRIL TABLET CAPTOPRIL (CAPTORPIL) TABLET [WOCKHARDT USA LLC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAPTOPRIL TABLET CAPTOPRIL (CAPTORPIL) TABLET [WOCKHARDT USA LLC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCAPTOPRIL TABLET [GLENVIEW PHARMA INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCAPTOPRIL TABLET CAPTOPRIL (CAPTORPIL) TABLET [WOCKHARDT USA LLC.]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 TABLET [AIDAREX PHARMACEUTICALS LLC]1
CAPTOPRILACTIVE MOIETY9G64RSX1XDCAPTOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCAPTOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCAPTOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]1
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1CAPTOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAPTOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCAPTOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCAPTOPRIL TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64679-902CAPTOPRIL TABLET [WOCKHARDT USA LLC.]8Legacy NDC20200117_4a3e016f-8c88-4041-9a56-0090b0cd170a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
308963captopril 12.5 MG Oral TabletPSN137ac94a-2461-4b33-9221-5ca80ed7a4171
308963captopril 12.5 MG Oral TabletSCD137ac94a-2461-4b33-9221-5ca80ed7a4171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64679-902-0164679090201100 TABLET in 1 BOTTLE (64679-902-01) 100 tablet1997-03-280000-00-00NoNoCurrent
64679-902-02646790902021000 TABLET in 1 BOTTLE (64679-902-02) 1000 tablet1997-03-280000-00-00NoNoCurrent
64679-902-056467909020520000 TABLET in 1 POUCH (64679-902-05) 20000 tablet1997-03-280000-00-00NoNoCurrent