Captopril

Product NDC
0904-7105
11-digit product format
009047105
Labeler code
0904
Product ID
0904-7105_ca598786-19c6-4d57-8e6f-26eaad0c13c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Captopril
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA212809
Marketing category
ANDA
Marketing start
2019-12-13
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
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
CAPTOPRIL12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9G64RSX1XD
Rxcui308963, 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
0904-7105-61Captopril100 in 1 CARTONTABLET1007
0904-7105-61Captopril1 in 1 BLISTER PACKTABLET17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7105-61EA - Each0904-71058230c565-f275-40d7-9cab-142eb452433912021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7105CAPTOPRIL TABLET [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 2 package rows20241222_a43a5373-ded9-4912-8c98-edaec8352836.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308963captopril 12.5 MG Oral TabletPSNa43a5373-ded9-4912-8c98-edaec83528367
317173captopril 25 MG Oral TabletPSNa43a5373-ded9-4912-8c98-edaec83528367
308963captopril 12.5 MG Oral TabletSCDa43a5373-ded9-4912-8c98-edaec83528367
317173captopril 25 MG Oral TabletSCDa43a5373-ded9-4912-8c98-edaec83528367

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7105-6100904710561100 BLISTER PACK in 1 CARTON (0904-7105-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2019-12-130000-00-00NoNoCurrent