FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
71205-761
11-digit product format
712050761
Labeler code
71205
Product ID
71205-761_e4009ade-155b-4d28-8a8d-555db68bf8b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078494
Marketing category
ANDA
Marketing start
2007-08-10
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
120 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 HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856460

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
71205-761-30Propranolol Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
71205-761-60Propranolol Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE601
71205-761-90Propranolol Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-761-30EA - Each71205-761bd00cb1e-cee1-4e54-9b7c-9de6b79af33a12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-761PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1Current NDC, 3 package rows20230212_e4009ade-155b-4d28-8a8d-555db68bf8b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856460propranolol HCl 120 MG 24HR Extended Release Oral CapsulePSNe4009ade-155b-4d28-8a8d-555db68bf8b01
85646024 HR propranolol hydrochloride 120 MG Extended Release Oral CapsuleSCDe4009ade-155b-4d28-8a8d-555db68bf8b01
856460propranolol hydrochloride 120 MG 24 HR Extended Release Oral CapsuleSYe4009ade-155b-4d28-8a8d-555db68bf8b01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-761-307120507613030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-761-30) 2023-02-09NoNoCurrent
71205-761-607120507616060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-761-60) 2023-02-09NoNoCurrent
71205-761-907120507619090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71205-761-90) 2023-02-09NoNoCurrent