CARVEDILOL

Product NDC
72789-440
11-digit product format
727890440
Labeler code
72789
Product ID
72789-440_4d7b0386-3253-2606-e063-6294a90a668b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARVEDILOL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078165
Marketing category
ANDA
Marketing start
2021-07-29
Substance
CARVEDILOL
Active strength
25 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
0K47UL67F2CARVEDILOL72956-09-3CARVEDILOL

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-440-907278904409090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-440-90) 2024-11-04NoNoHistorical
72789-440-9372789044093180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-440-93) 2024-10-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CARVEDILOLPD-Rx Pharmaceuticals, Inc.2026-03-20HUMAN PRESCRIPTION DRUG LABEL6
CARVEDILOLPD-Rx Pharmaceuticals, Inc.2025-10-23HUMAN PRESCRIPTION DRUG LABEL5
CARVEDILOLPD-Rx Pharmaceuticals, Inc.2024-11-04HUMAN PRESCRIPTION DRUG LABEL3