FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
50090-0420
11-digit product format
500900420
Labeler code
50090
Product ID
50090-0420_1259f5f5-c975-42fc-9090-30fef2e33f4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078494
Marketing category
ANDA
Marketing start
2007-08-10
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0420-02023-01-30C16284748780-1f386c64a-20e0-0266-e053-dadaa90a7c1aPROPRANOLOL HYDROCHLORIDE EXTENDED-RELEASE CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0420-0Propranolol Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0420-0EA - Each50090-04204017bace-1cac-4938-b5f0-b48a6a920ec512018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0420PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]9Legacy NDC, 1 package rows20210415_bde91bcf-c484-4b19-a160-ecdd3f64fba7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSNbde91bcf-c484-4b19-a160-ecdd3f64fba79
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCDbde91bcf-c484-4b19-a160-ecdd3f64fba79
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSYbde91bcf-c484-4b19-a160-ecdd3f64fba79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0420-05009004200030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-0420-0) 2014-11-280000-00-00NoNoCurrent