captopril

Product NDC
58657-935
11-digit product format
586570935
Labeler code
58657
Product ID
58657-935_457502be-feb2-5e2f-e063-6394a90aec0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
captopril
Dosage form
TABLET
Route
ORAL
Labeler
Method Pharmaceuticals LLC
Application
ANDA074677
Marketing category
ANDA
Marketing start
2025-12-01
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
58657-935-01captopril100 in 1 CARTONTABLET1003
58657-935-03captopril30 in 1 CARTONTABLET303
58657-935-10captopril1 in 1 BLISTER PACKTABLET13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-935-01EA - Each58657-935b0f972d8-d2d6-453e-b583-f4e00c70882912026-02-05
58657-935-03EA - Each58657-93566c5125b-5aa2-4df2-9687-450d72eaf31012026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308962captopril 100 MG Oral TabletPSN1a91ac7f-b75d-d111-e063-6394a90a2a933
308963captopril 12.5 MG Oral TabletPSN1a91ac7f-b75d-d111-e063-6394a90a2a933
317173captopril 25 MG Oral TabletPSN1a91ac7f-b75d-d111-e063-6394a90a2a933
308964captopril 50 MG Oral TabletPSN1a91ac7f-b75d-d111-e063-6394a90a2a933
308962captopril 100 MG Oral TabletSCD1a91ac7f-b75d-d111-e063-6394a90a2a933
308963captopril 12.5 MG Oral TabletSCD1a91ac7f-b75d-d111-e063-6394a90a2a933
317173captopril 25 MG Oral TabletSCD1a91ac7f-b75d-d111-e063-6394a90a2a933
308964captopril 50 MG Oral TabletSCD1a91ac7f-b75d-d111-e063-6394a90a2a933

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58657-935-0158657093501100 BLISTER PACK in 1 CARTON (58657-935-01) / 1 TABLET in 1 BLISTER PACK (58657-935-10) 100 blister pack2025-12-01NoNoCurrent
58657-935-035865709350330 BLISTER PACK in 1 CARTON (58657-935-03) / 1 TABLET in 1 BLISTER PACK (58657-935-10) 30 blister pack2025-12-01NoNoCurrent
58657-935-10586570935101 in 1 BLISTER PACKHistorical