FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
62559-532
11-digit product format
625590532
Labeler code
62559
Product ID
62559-532_200aecd3-b441-4856-a9fc-6841ada5489c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
NDA018553
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2017-12-21
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

Additional Listing Data#

Finished product
Yes
Brand name base
Propranolol Hydrochloride
Brand name suffix
ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856460, 856481, 856535, 856569

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba1babb5-1c2a-d9a8-0fd7-8f90d4f768cfProduct name220200609
a5696e6c-a559-4d6b-bb53-f324106f317cProduct name120140718
0f446d3d-c9e6-1844-b8e8-a836dc35e0deProduct name120140508
33a4b7b4-a3c1-3f95-a202-01166dd77c44Product name120140508
60519d27-227d-404a-38bc-37524c8b386bProduct name120140508
d5f30598-8f94-b083-f161-65d67f2ae12aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-532-01Propranolol HydrochlorideER100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-532-01EA - Each62559-5323a36366b-1371-4975-b3ae-8aee7d18c32012018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-532PROPRANOLOL HYDROCHLORIDE ER (PROPRANOLOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 1 package rows20240802_5415904b-90da-48e8-9f9e-f86749aa129c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856460propranolol HCl 120 MG 24HR Extended Release Oral CapsulePSN5415904b-90da-48e8-9f9e-f86749aa129c9
856481propranolol HCl 160 MG 24HR Extended Release Oral CapsulePSN5415904b-90da-48e8-9f9e-f86749aa129c9
856535propranolol HCl 60 MG 24HR Extended Release Oral CapsulePSN5415904b-90da-48e8-9f9e-f86749aa129c9
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSN5415904b-90da-48e8-9f9e-f86749aa129c9
85646024 HR propranolol hydrochloride 120 MG Extended Release Oral CapsuleSCD5415904b-90da-48e8-9f9e-f86749aa129c9
85648124 HR propranolol hydrochloride 160 MG Extended Release Oral CapsuleSCD5415904b-90da-48e8-9f9e-f86749aa129c9
85653524 HR propranolol hydrochloride 60 MG Extended Release Oral CapsuleSCD5415904b-90da-48e8-9f9e-f86749aa129c9
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCD5415904b-90da-48e8-9f9e-f86749aa129c9
856460propranolol hydrochloride 120 MG 24 HR Extended Release Oral CapsuleSY5415904b-90da-48e8-9f9e-f86749aa129c9
856481propranolol hydrochloride 160 MG 24 HR Extended Release Oral CapsuleSY5415904b-90da-48e8-9f9e-f86749aa129c9
856535propranolol hydrochloride 60 MG 24 HR Extended Release Oral CapsuleSY5415904b-90da-48e8-9f9e-f86749aa129c9
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSY5415904b-90da-48e8-9f9e-f86749aa129c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62559-532-0162559053201100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-532-01) 2017-12-210000-00-00NoNoCurrent