FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
0054-3727
11-digit product format
000543727
Labeler code
0054
Product ID
0054-3727_245a43cc-cbf8-486d-ad3c-724aca63fd72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
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, 856733

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
d5f30598-8f94-b083-f161-65d67f2ae12aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-3727-63Propranolol Hydrochloride500 mL in 1 BOTTLE, PLASTICSOLUTION50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-3727-63ML - Milliliter0054-37278f449ee4-5248-40cd-8d8d-c102d1a34d0f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPRANOLOL HYDROCHLORIDEACTIVE INGREDIENTF8A3652H1VPROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]6
PROPRANOLOLACTIVE MOIETY9Y8NXQ24VQPROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]6
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]6
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFPROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]6
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]6
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]6
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]6
SORBITOLINACTIVE INGREDIENT506T60A25RPROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]6
WATERINACTIVE INGREDIENT059QF0KO0RPROPRANOLOL HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-3727PROPRANOLOL HYDROCHLORIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]11Current NDC, Legacy NDC, 1 package rows20241206_8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856724propranolol HCl 20 MG in 5 mL Oral SolutionPSN8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e11
856733propranolol HCl 40 MG in 5 mL Oral SolutionPSN8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e11
856724propranolol hydrochloride 4 MG/ML Oral SolutionSCD8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e11
856733propranolol hydrochloride 8 MG/ML Oral SolutionSCD8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e11
856724propranolol hydrochloride 20 MG per 5 ML Oral SolutionSY8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e11
856733propranolol hydrochloride 40 MG per 5 ML Oral SolutionSY8fe0a04c-bf5b-4ba0-9df6-58c27f24b52e11
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
856724propranolol HCl 20 MG in 5 mL Oral SolutionPSNec5c919b-05d1-45d2-a6e4-ac4ae1101dbb4
856724propranolol hydrochloride 4 MG/ML Oral SolutionSCDec5c919b-05d1-45d2-a6e4-ac4ae1101dbb4
856724propranolol hydrochloride 20 MG per 5 ML Oral SolutionSYec5c919b-05d1-45d2-a6e4-ac4ae1101dbb4
856724propranolol HCl 20 MG in 5 mL Oral SolutionPSN73124cb1-3763-49b0-8317-e307050480532
856724propranolol HCl 20 MG in 5 mL Oral SolutionPSN2f69cab3-e04d-44ab-adb6-9d01169f4f002
856724propranolol hydrochloride 4 MG/ML Oral SolutionSCD73124cb1-3763-49b0-8317-e307050480532
856724propranolol hydrochloride 4 MG/ML Oral SolutionSCD2f69cab3-e04d-44ab-adb6-9d01169f4f002
856724propranolol hydrochloride 20 MG per 5 ML Oral SolutionSY73124cb1-3763-49b0-8317-e307050480532
856724propranolol hydrochloride 20 MG per 5 ML Oral SolutionSY2f69cab3-e04d-44ab-adb6-9d01169f4f002
856724propranolol HCl 20 MG in 5 mL Oral SolutionPSN40333bee-749f-0b43-e063-6394a90a149c1
856724propranolol hydrochloride 4 MG/ML Oral SolutionSCD40333bee-749f-0b43-e063-6394a90a149c1
856724propranolol hydrochloride 20 MG per 5 ML Oral SolutionSY40333bee-749f-0b43-e063-6394a90a149c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-3727-6300054372763500 mL in 1 BOTTLE, PLASTIC (0054-3727-63) 500 ml1987-05-150000-00-00NoNoCurrent