Carvedilol

Product NDC: 82804-183
11-digit product format: 828040183
Labeler code: 82804
Product ID: 82804-183_a1344411-fc64-4233-89ba-e90a1953e150
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carvedilol
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA078384
Marketing category: ANDA
Marketing start: 2016-10-01
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: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 82804-183_a1344411-fc64-4233-89ba-e90a1953e150
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Carvedilol
Generic name: Carvedilol
Dosage form: TABLET, FILM COATED
Route: ORAL
Marketing start: 2016-10-01
Marketing category: ANDA
Application number: ANDA078384
Pharmacologic classes: Adrenergic alpha-Antagonists [MoA]; Adrenergic beta1-Antagonists [MoA]; Adrenergic beta2-Antagonists [MoA]; alpha-Adrenergic Blocker [EPC]; beta-Adrenergic Blocker [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
CARVEDILOL	25 mg/1

UNII	Preferred term	Registry number	Matched term
0K47UL67F2	CARVEDILOL	72956-09-3	CARVEDILOL

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82804-183-90	82804018390	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-183-90)	2025-02-04	No	No	Current

Title	Manufacturer	Effective date	Type	Version
Carvedilol	Proficient Rx LP	2025-03-01	HUMAN PRESCRIPTION DRUG LABEL	1