FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
82868-003
11-digit product format
828680003
Labeler code
82868
Product ID
82868-003_46dc87c7-cc52-3e0c-e063-6294a90aff3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA071972
Marketing category
ANDA
Marketing start
2023-08-15
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
20 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856457

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
82868-003-30Propranolol Hydrochloride30 in 1 BOTTLE, PLASTICTABLET303
82868-003-90Propranolol Hydrochloride90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82868-003PROPRANOLOL HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240627_03afbc5a-a9dc-e823-e063-6394a90a0cb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856457propranolol HCl 20 MG Oral TabletPSN03afbc5a-a9dc-e823-e063-6394a90a0cb23
856457propranolol hydrochloride 20 MG Oral TabletSCD03afbc5a-a9dc-e823-e063-6394a90a0cb23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82868-003-308286800033030 TABLET in 1 BOTTLE, PLASTIC (82868-003-30) 30 tablet2023-08-15NoNoHistorical
82868-003-908286800039090 TABLET in 1 BOTTLE, PLASTIC (82868-003-90) 90 tablet2024-04-29NoNoHistorical