FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
71610-339
11-digit product format
716100339
Labeler code
71610
Product ID
71610-339_c8c0bd51-a7c2-4d89-bee2-063cd4da43f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA070213
Marketing category
ANDA
Marketing start
1985-11-19
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
71610-339-45Propranolol Hydrochloride45 in 1 BOTTLE, PLASTICTABLET452
71610-339-60Propranolol Hydrochloride90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-339-45EA - Each71610-339d7bf1531-bf4c-4b80-b6c9-e6f28a8580d212021-08-05
71610-339-60EA - Each71610-339b5564454-1a0e-492e-8478-b07e3725f77912019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-339PROPRANOLOL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 2 package rows20210703_3c05ab1f-05b0-494a-b640-667e7cf517a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856457propranolol HCl 20 MG Oral TabletPSN3c05ab1f-05b0-494a-b640-667e7cf517a12
856457propranolol hydrochloride 20 MG Oral TabletSCD3c05ab1f-05b0-494a-b640-667e7cf517a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-339-457161003394545 TABLET in 1 BOTTLE, PLASTIC (71610-339-45) 45 tablet2021-05-070000-00-00NoNoCurrent
71610-339-607161003396090 TABLET in 1 BOTTLE, PLASTIC (71610-339-60) 90 tablet2019-08-200000-00-00NoNoCurrent