FDA.reportPublic FDA data

Captopril

Product NDC
0143-1171
11-digit product format
001431171
Labeler code
0143
Product ID
0143-1171_dcd9332a-1256-457f-900a-b658c6d619c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Captopril
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA074505
Marketing category
ANDA
Marketing start
1996-02-13
Substance
CAPTOPRIL
Active strength
12.5 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Captopril
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPTOPRIL12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9G64RSX1XD
Rxcui308962, 308963, 308964, 317173

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5efca61-58ec-b4d0-77f8-f2b1fb112156Product name420240223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-1171-01Captopril100 in 1 BOTTLETABLET10029
0143-1171-10Captopril1000 in 1 BOTTLETABLET100029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-1171-01EA - Each0143-1171bea7623f-3f51-4d63-be73-778f58ccd2be12012-07-24
0143-1171-10EA - Each0143-1171f7d6780b-0130-4cd6-8af6-ce087409bdc912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPTOPRILACTIVE INGREDIENT9G64RSX1XDCAPTOPRIL TABLET [WEST-WARD PHARMACEUTICALS CORP]12
CAPTOPRILACTIVE MOIETY9G64RSX1XDCAPTOPRIL TABLET [WEST-WARD PHARMACEUTICALS CORP]12
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCAPTOPRIL TABLET [WEST-WARD PHARMACEUTICALS CORP]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCAPTOPRIL TABLET [WEST-WARD PHARMACEUTICALS CORP]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAPTOPRIL TABLET [WEST-WARD PHARMACEUTICALS CORP]12
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CAPTOPRIL TABLET [WEST-WARD PHARMACEUTICALS CORP]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCAPTOPRIL TABLET [WEST-WARD PHARMACEUTICALS CORP]12
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TCAPTOPRIL TABLET [WEST-WARD PHARMACEUTICALS CORP]12
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCAPTOPRIL TABLET [WEST-WARD PHARMACEUTICALS CORP]12
CAPTOPRILACTIVE INGREDIENT9G64RSX1XDCAPTOPRIL TABLET [PHYSICIANS TOTAL CARE, INC.]3
CAPTOPRILACTIVE MOIETY9G64RSX1XDCAPTOPRIL TABLET [PHYSICIANS TOTAL CARE, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCAPTOPRIL TABLET [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCAPTOPRIL TABLET [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CAPTOPRIL TABLET [PHYSICIANS TOTAL CARE, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CAPTOPRIL TABLET [PHYSICIANS TOTAL CARE, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCAPTOPRIL TABLET [PHYSICIANS TOTAL CARE, INC.]3
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TCAPTOPRIL TABLET [PHYSICIANS TOTAL CARE, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCAPTOPRIL TABLET [PHYSICIANS TOTAL CARE, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-1171CAPTOPRIL TABLET [HIKMA PHARMACEUTICALS USA INC.]29Current NDC, Legacy NDC, 2 package rows20241228_607687f4-63cf-411c-a20b-21d238a6b7a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308962captopril 100 MG Oral TabletPSN607687f4-63cf-411c-a20b-21d238a6b7a729
308963captopril 12.5 MG Oral TabletPSN607687f4-63cf-411c-a20b-21d238a6b7a729
317173captopril 25 MG Oral TabletPSN607687f4-63cf-411c-a20b-21d238a6b7a729
308964captopril 50 MG Oral TabletPSN607687f4-63cf-411c-a20b-21d238a6b7a729
308962captopril 100 MG Oral TabletSCD607687f4-63cf-411c-a20b-21d238a6b7a729
308963captopril 12.5 MG Oral TabletSCD607687f4-63cf-411c-a20b-21d238a6b7a729
317173captopril 25 MG Oral TabletSCD607687f4-63cf-411c-a20b-21d238a6b7a729
308964captopril 50 MG Oral TabletSCD607687f4-63cf-411c-a20b-21d238a6b7a729
308963captopril 12.5 MG Oral TabletPSN9b54feb0-13cd-46a8-9924-f128803811967
317173captopril 25 MG Oral TabletPSN9b54feb0-13cd-46a8-9924-f128803811967
308963captopril 12.5 MG Oral TabletSCD9b54feb0-13cd-46a8-9924-f128803811967
317173captopril 25 MG Oral TabletSCD9b54feb0-13cd-46a8-9924-f128803811967
308962captopril 100 MG Oral TabletPSNd117c8bd-50a8-7355-e053-2a95a90ac70f5
308963captopril 12.5 MG Oral TabletPSNd117c8bd-50a8-7355-e053-2a95a90ac70f5
317173captopril 25 MG Oral TabletPSNd117c8bd-50a8-7355-e053-2a95a90ac70f5
308964captopril 50 MG Oral TabletPSNd117c8bd-50a8-7355-e053-2a95a90ac70f5
308962captopril 100 MG Oral TabletSCDd117c8bd-50a8-7355-e053-2a95a90ac70f5
308963captopril 12.5 MG Oral TabletSCDd117c8bd-50a8-7355-e053-2a95a90ac70f5
317173captopril 25 MG Oral TabletSCDd117c8bd-50a8-7355-e053-2a95a90ac70f5
308964captopril 50 MG Oral TabletSCDd117c8bd-50a8-7355-e053-2a95a90ac70f5
308962captopril 100 MG Oral TabletPSN1e1eb843-4fcd-4329-94ec-720a529702533
308963captopril 12.5 MG Oral TabletPSN1e1eb843-4fcd-4329-94ec-720a529702533
317173captopril 25 MG Oral TabletPSN1e1eb843-4fcd-4329-94ec-720a529702533
308964captopril 50 MG Oral TabletPSN1e1eb843-4fcd-4329-94ec-720a529702533
308962captopril 100 MG Oral TabletSCD1e1eb843-4fcd-4329-94ec-720a529702533
308963captopril 12.5 MG Oral TabletSCD1e1eb843-4fcd-4329-94ec-720a529702533
317173captopril 25 MG Oral TabletSCD1e1eb843-4fcd-4329-94ec-720a529702533
308964captopril 50 MG Oral TabletSCD1e1eb843-4fcd-4329-94ec-720a529702533

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-1171-0100143117101100 TABLET in 1 BOTTLE (0143-1171-01) 100 tablet1996-02-130000-00-00NoNoCurrent
0143-1171-10001431171101000 TABLET in 1 BOTTLE (0143-1171-10) 1000 tablet1996-02-130000-00-00NoNoCurrent