FDA.reportPublic FDA data

PROPRANOLOL HYDROCHLORIDE

Product NDC
72189-018
11-digit product format
721890018
Labeler code
72189
Product ID
72189-018_8ed46816-31c5-3351-e053-2a95a90aa244
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROPRANOLOL HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA078703
Marketing category
ANDA
Marketing start
2019-07-29
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
2020-12-31
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
72189-018-302023-01-30C16284748780-1f386c649-e3a8-0266-e053-dadaa90a7c1aPROPRANOLOL HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-018-30PROPRANOLOL HYDROCHLORIDE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-018PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT_RX]1Legacy NDC, 1 package rows20190730_8ed46816-31c4-3351-e053-2a95a90aa244.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSN8ed46816-31c4-3351-e053-2a95a90aa2441
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCD8ed46816-31c4-3351-e053-2a95a90aa2441
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSY8ed46816-31c4-3351-e053-2a95a90aa2441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-018-307218900183030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-018-30) 2019-07-290000-00-00NoNoCurrent