propranolol hydrochloride

Product NDC: 82804-072
11-digit product format: 828040072
Labeler code: 82804
Product ID: 82804-072_1d7c1de3-3cf4-4b1e-bdcc-55f423c88001
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: propranolol hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA078703
Marketing category: ANDA
Marketing start: 2013-03-11
Substance: PROPRANOLOL HYDROCHLORIDE
Active strength: 60 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 82804-072_1d7c1de3-3cf4-4b1e-bdcc-55f423c88001
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: propranolol hydrochloride
Generic name: propranolol hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Marketing start: 2013-03-11
Marketing category: ANDA
Application number: ANDA078703
Pharmacologic classes: Adrenergic beta-Antagonists [MoA]; beta-Adrenergic Blocker [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
PROPRANOLOL HYDROCHLORIDE	60 mg/1

UNII	Preferred term	Registry number	Matched term
F8A3652H1V	PROPRANOLOL HYDROCHLORIDE	318-98-9	PROPRANOLOL HYDROCHLORIDE

Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82804-072-30	82804007230	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (82804-072-30)	2024-02-09	No	No	Current
82804-072-60	82804007260	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (82804-072-60)	2024-02-09	No	No	Current
82804-072-90	82804007290	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (82804-072-90)	2024-02-09	No	No	Current

Title	Manufacturer	Effective date	Type	Version
Propranolol Hydrochloride Extended-Release Capsules, USP	Proficient Rx LP	2024-02-01	HUMAN PRESCRIPTION DRUG LABEL	1