FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
17856-3728
11-digit product format
178563728
Labeler code
17856
Product ID
17856-3728_35d2e40e-8f0d-ef2d-e063-6294a90aadc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA070979
Marketing category
ANDA
Marketing start
1987-05-15
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
20 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856724

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-3728-12024-05-10C16284748780-19d75b9d1-1f89-f424-e053-dadaa90a57cePropanolol Hydrochloride Oral Solution
17856-3728-12023-01-30C16284748780-19d75b9d1-1f89-f424-e053-dadaa90a57cePropanolol Hydrochloride Oral Solution
17856-3728-12021-05-05C16284748780-19d75b9d1-1f89-f424-e053-dadaa90a57cePropanolol Hydrochloride Oral Solution
17856-3728-12020-01-31C16284748780-19d75b9d1-1f89-f424-e053-dadaa90a57cePropanolol Hydrochloride Oral Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-3728-1Propranolol Hydrochloride5 mL in 1 CUPSOLUTION55
17856-3728-1Propranolol Hydrochloride72 in 1 CASESOLUTION725

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-3728-1ML - Milliliter17856-37282ed300d0-8624-4068-83b6-53673823bbde12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-3728PROPRANOLOL HYDROCHLORIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.]5Current NDC, Legacy NDC, 2 package rows20250525_b609cc7c-1f6a-452b-8ada-c4d2989b83dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856724propranolol HCl 20 MG in 5 mL Oral SolutionPSNb609cc7c-1f6a-452b-8ada-c4d2989b83dc5
856724propranolol hydrochloride 4 MG/ML Oral SolutionSCDb609cc7c-1f6a-452b-8ada-c4d2989b83dc5
856724propranolol hydrochloride 20 MG per 5 ML Oral SolutionSYb609cc7c-1f6a-452b-8ada-c4d2989b83dc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-3728-11785637280172 CUP in 1 CASE (17856-3728-1) / 5 mL in 1 CUP72 cup2024-05-100000-00-00NoNoCurrent