FDA.reportPublic FDA data

captopril

Product NDC
58657-735
11-digit product format
586570735
Labeler code
58657
Product ID
58657-735_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
2024-06-15
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
58657-735-01captopril100 in 1 BOTTLETABLET1003
58657-735-10captopril1000 in 1 BOTTLETABLET10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-735-01EA - Each58657-735d36bbcf8-d920-4039-aeee-38560d88771c12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-735CAPTOPRIL TABLET [METHOD PHARMACEUTICALS LLC]1Current NDC, 2 package rows20240617_1a91ac7f-b75d-d111-e063-6394a90a2a93.zip

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
58657-735-0158657073501100 TABLET in 1 BOTTLE (58657-735-01) 100 tablet2024-06-15NoNoCurrent
58657-735-10586570735101000 TABLET in 1 BOTTLE (58657-735-10) 1000 tablet2024-06-15NoNoCurrent