FDA.reportPublic FDA data

Captopril

Product NDC
31722-142
11-digit product format
317220142
Labeler code
31722
Product ID
31722-142_99fac9d2-a1a4-40c3-8530-098acc7e16c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Captopril
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA074737
Marketing category
ANDA
Marketing start
2005-12-07
Substance
CAPTOPRIL
Active strength
25 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
CAPTOPRIL25 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
31722-142-01Captopril100 in 1 BOTTLETABLET1009
31722-142-10Captopril1000 in 1 BOTTLETABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-142-01EA - Each31722-142f1162cd4-2190-4093-ad50-099b71b56fec12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-142CAPTOPRIL (CAPTOPRIL ) TABLET CAPTOPRIL TABLET [CAMBER PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 2 package rows20231227_5b44ab6e-6cd9-4e12-b9be-d2e4d954acb5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308962captopril 100 MG Oral TabletPSN5b44ab6e-6cd9-4e12-b9be-d2e4d954acb59
308963captopril 12.5 MG Oral TabletPSN5b44ab6e-6cd9-4e12-b9be-d2e4d954acb59
317173captopril 25 MG Oral TabletPSN5b44ab6e-6cd9-4e12-b9be-d2e4d954acb59
308964captopril 50 MG Oral TabletPSN5b44ab6e-6cd9-4e12-b9be-d2e4d954acb59
308962captopril 100 MG Oral TabletSCD5b44ab6e-6cd9-4e12-b9be-d2e4d954acb59
308963captopril 12.5 MG Oral TabletSCD5b44ab6e-6cd9-4e12-b9be-d2e4d954acb59
317173captopril 25 MG Oral TabletSCD5b44ab6e-6cd9-4e12-b9be-d2e4d954acb59
308964captopril 50 MG Oral TabletSCD5b44ab6e-6cd9-4e12-b9be-d2e4d954acb59
308963captopril 12.5 MG Oral TabletPSN3362b7a8-026a-b277-e063-6394a90a9dc61
317173captopril 25 MG Oral TabletPSN3362b7a8-026a-b277-e063-6394a90a9dc61
308964captopril 50 MG Oral TabletPSN3362b7a8-026a-b277-e063-6394a90a9dc61
308963captopril 12.5 MG Oral TabletSCD3362b7a8-026a-b277-e063-6394a90a9dc61
317173captopril 25 MG Oral TabletSCD3362b7a8-026a-b277-e063-6394a90a9dc61
308964captopril 50 MG Oral TabletSCD3362b7a8-026a-b277-e063-6394a90a9dc61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-142-0131722014201100 TABLET in 1 BOTTLE (31722-142-01) 100 tablet2021-07-080000-00-00NoNoCurrent
31722-142-10317220142101000 TABLET in 1 BOTTLE (31722-142-10) 1000 tablet2021-07-080000-00-00NoNoCurrent