FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
68788-7860
11-digit product format
687887860
Labeler code
68788
Product ID
68788-7860_e950e99d-b2b0-4d20-ad5f-a20f055463e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA070322
Marketing category
ANDA
Marketing start
2021-02-08
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856448

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
68788-7860-3Propranolol Hydrochloride30 in 1 BOTTLETABLET305
68788-7860-9Propranolol Hydrochloride90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7860-3EA - Each68788-786004dffa24-5591-4959-858f-93cf75c1c59b12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7860PROPRANOLOL HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20240805_86c48c5a-0a59-43a7-b3b5-41ab5da72ce1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSN86c48c5a-0a59-43a7-b3b5-41ab5da72ce15
856448propranolol hydrochloride 10 MG Oral TabletSCD86c48c5a-0a59-43a7-b3b5-41ab5da72ce15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7860-36878878600330 TABLET in 1 BOTTLE (68788-7860-3) 30 tablet2021-02-080000-00-00NoNoCurrent
68788-7860-96878878600990 TABLET in 1 BOTTLE (68788-7860-9) 90 tablet2024-08-02NoNoHistorical