Captopril

Product NDC
11788-138
11-digit product format
117880138
Labeler code
11788
Product ID
11788-138_8e531d13-c832-4fc0-a405-d63050458879
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Captopril
Dosage form
TABLET
Route
ORAL
Labeler
AiPing Pharmaceutical, Inc.
Application
ANDA214442
Marketing category
ANDA
Marketing start
2026-04-01
Substance
CAPTOPRIL
Active strength
100 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Captopril
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPTOPRIL100 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
11788-138-01Captopril100 in 1 BOTTLETABLET1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308962captopril 100 MG Oral TabletPSN3b789f16-b291-4012-be39-af3beec3ff9a1
308963captopril 12.5 MG Oral TabletPSN3b789f16-b291-4012-be39-af3beec3ff9a1
317173captopril 25 MG Oral TabletPSN3b789f16-b291-4012-be39-af3beec3ff9a1
308964captopril 50 MG Oral TabletPSN3b789f16-b291-4012-be39-af3beec3ff9a1
308962captopril 100 MG Oral TabletSCD3b789f16-b291-4012-be39-af3beec3ff9a1
308963captopril 12.5 MG Oral TabletSCD3b789f16-b291-4012-be39-af3beec3ff9a1
317173captopril 25 MG Oral TabletSCD3b789f16-b291-4012-be39-af3beec3ff9a1
308964captopril 50 MG Oral TabletSCD3b789f16-b291-4012-be39-af3beec3ff9a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11788-138-0111788013801100 TABLET in 1 BOTTLE (11788-138-01) 100 tablet2026-04-01NoNoCurrent