FDA.reportPublic FDA data

propranolol hydrochloride

Product NDC
42291-523
11-digit product format
422910523
Labeler code
42291
Product ID
42291-523_4b93e61b-2f17-4421-e063-6394a90ae3f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA078703
Marketing category
ANDA
Marketing start
2017-05-16
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
80 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
propranolol hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE80 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
42291-523-01propranolol hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1009
42291-523-10propranolol hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-523PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AVKARE]7Current NDC, Legacy NDC, 2 package rows20240110_753ab3cb-e7ee-424b-aa7d-195b5871a40e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856460propranolol HCl 120 MG 24HR Extended Release Oral CapsulePSN753ab3cb-e7ee-424b-aa7d-195b5871a40e9
856481propranolol HCl 160 MG 24HR Extended Release Oral CapsulePSN753ab3cb-e7ee-424b-aa7d-195b5871a40e9
856535propranolol HCl 60 MG 24HR Extended Release Oral CapsulePSN753ab3cb-e7ee-424b-aa7d-195b5871a40e9
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSN753ab3cb-e7ee-424b-aa7d-195b5871a40e9
85646024 HR propranolol hydrochloride 120 MG Extended Release Oral CapsuleSCD753ab3cb-e7ee-424b-aa7d-195b5871a40e9
85648124 HR propranolol hydrochloride 160 MG Extended Release Oral CapsuleSCD753ab3cb-e7ee-424b-aa7d-195b5871a40e9
85653524 HR propranolol hydrochloride 60 MG Extended Release Oral CapsuleSCD753ab3cb-e7ee-424b-aa7d-195b5871a40e9
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCD753ab3cb-e7ee-424b-aa7d-195b5871a40e9
856460propranolol hydrochloride 120 MG 24 HR Extended Release Oral CapsuleSY753ab3cb-e7ee-424b-aa7d-195b5871a40e9
856481propranolol hydrochloride 160 MG 24 HR Extended Release Oral CapsuleSY753ab3cb-e7ee-424b-aa7d-195b5871a40e9
856535propranolol hydrochloride 60 MG 24 HR Extended Release Oral CapsuleSY753ab3cb-e7ee-424b-aa7d-195b5871a40e9
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSY753ab3cb-e7ee-424b-aa7d-195b5871a40e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-523-0142291052301100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-523-01) 2017-05-160000-00-00NoNoCurrent
42291-523-10422910523101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-523-10) 2017-07-310000-00-00NoNoCurrent