Captopril

Product NDC
43547-366
11-digit product format
435470366
Labeler code
43547
Product ID
43547-366_cdf43721-a18a-42c8-8354-ae99e7be261a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Captopril
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA074477
Marketing category
ANDA
Marketing start
2016-07-01
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
43547-366-10Captopril100 in 1 BOTTLETABLET1002
43547-366-11Captopril1000 in 1 BOTTLETABLET10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-366CAPTOPRIL TABLET [SOLCO HEALTHCARE US, LLC]1Current NDC, 2 package rows20230527_2d3779b0-83d9-4b6f-a043-f7768cd7fce6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308962captopril 100 MG Oral TabletPSN2d3779b0-83d9-4b6f-a043-f7768cd7fce62
308963captopril 12.5 MG Oral TabletPSN2d3779b0-83d9-4b6f-a043-f7768cd7fce62
317173captopril 25 MG Oral TabletPSN2d3779b0-83d9-4b6f-a043-f7768cd7fce62
308964captopril 50 MG Oral TabletPSN2d3779b0-83d9-4b6f-a043-f7768cd7fce62
308962captopril 100 MG Oral TabletSCD2d3779b0-83d9-4b6f-a043-f7768cd7fce62
308963captopril 12.5 MG Oral TabletSCD2d3779b0-83d9-4b6f-a043-f7768cd7fce62
317173captopril 25 MG Oral TabletSCD2d3779b0-83d9-4b6f-a043-f7768cd7fce62
308964captopril 50 MG Oral TabletSCD2d3779b0-83d9-4b6f-a043-f7768cd7fce62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43547-366-1043547036610100 TABLET in 1 BOTTLE (43547-366-10) 100 tablet2016-07-01NoNoCurrent
43547-366-11435470366111000 in 1 BOTTLEHistorical