FDA.reportPublic FDA data

propranolol hydrochloride

Product NDC
82804-072
11-digit product format
828040072
Labeler code
82804
Product ID
82804-072_1d7c1de3-3cf4-4b1e-bdcc-55f423c88001
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078703
Marketing category
ANDA
Marketing start
2013-03-11
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
60 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 HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856535

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
82804-072-30propranolol hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
82804-072-60propranolol hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE601
82804-072-90propranolol hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-072-30EA - Each82804-07245ca52ba-3d48-4812-8c49-950e950f57b612024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-072PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [PROFICIENT RX LP]1Current NDC, 3 package rows20240216_1d7c1de3-3cf4-4b1e-bdcc-55f423c88001.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856535propranolol HCl 60 MG 24HR Extended Release Oral CapsulePSN1d7c1de3-3cf4-4b1e-bdcc-55f423c880011
85653524 HR propranolol hydrochloride 60 MG Extended Release Oral CapsuleSCD1d7c1de3-3cf4-4b1e-bdcc-55f423c880011
856535propranolol hydrochloride 60 MG 24 HR Extended Release Oral CapsuleSY1d7c1de3-3cf4-4b1e-bdcc-55f423c880011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-072-308280400723030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (82804-072-30) 2024-02-09NoNoCurrent
82804-072-608280400726060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (82804-072-60) 2024-02-09NoNoCurrent
82804-072-908280400729090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (82804-072-90) 2024-02-09NoNoCurrent