propranolol hydrochloride

Product NDC
63629-9282
11-digit product format
636299282
Labeler code
63629
Product ID
63629-9282_7c1c7b8f-827d-42fb-9ce3-94767b8455d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078703
Marketing category
ANDA
Marketing start
2013-03-11
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
120 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
63629-9282_7c1c7b8f-827d-42fb-9ce3-94767b8455d3
SPL ID
7c1c7b8f-827d-42fb-9ce3-94767b8455d3
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

openFDA Active Ingredients

IngredientStrength
PROPRANOLOL HYDROCHLORIDE120 mg/1

openFDA Harmonized Identifiers

FieldValues
UniiF8A3652H1V
Rxcui856460
Spl Set Idc5ad5449-b93e-4f26-977b-c66466d8ac6f
Manufacturer NameBryant Ranch Prepack

openFDA Package Details

Package NDCDescriptionMarketing startSample
63629-9282-1100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-9282-1)2022-06-06No

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
F8A3652H1VPROPRANOLOL HYDROCHLORIDE318-98-9PROPRANOLOL HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63629-9282-163629928201100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-9282-1) 2022-06-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Propranolol Hydrochloride Extended-Release Capsules, USPBryant Ranch Prepack2025-09-10HUMAN PRESCRIPTION DRUG LABEL102