Propranolol Hydrochloride

Product NDC
70518-3552
11-digit product format
705183552
Labeler code
70518
Product ID
70518-3552_4f58dd6f-ca42-9b96-e063-6394a90a5872
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA212026
Marketing category
ANDA
Marketing start
2022-10-09
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Propranolol Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856569

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
70518-3552-0Propranolol Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3552PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.]4Current NDC, Legacy NDC, 1 package rows20241121_414c4b69-38a1-4220-bec8-204c9a624b85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856569propranolol HCl 80 MG 24HR Extended Release Oral CapsulePSN414c4b69-38a1-4220-bec8-204c9a624b856
85656924 HR propranolol hydrochloride 80 MG Extended Release Oral CapsuleSCD414c4b69-38a1-4220-bec8-204c9a624b856
856569propranolol hydrochloride 80 MG 24 HR Extended Release Oral CapsuleSY414c4b69-38a1-4220-bec8-204c9a624b856

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3552-07051835520090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3552-0) 2022-10-090000-00-00NoNoCurrent