FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
0143-9872
11-digit product format
001439872
Labeler code
0143
Product ID
0143-9872_4432e36f-bed0-4e42-87aa-1330d1725963
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA077760
Marketing category
ANDA
Marketing start
2008-01-31
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
1 mg/mL
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 HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856443

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
0143-9872-01Propranolol Hydrochloride1 mL in 1 VIALINJECTION17
0143-9872-10Propranolol Hydrochloride10 in 1 CARTONINJECTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9872-01ML - Milliliter0143-9872089c2f97-f29b-400f-a233-2d80c02d30d312012-07-24
0143-9872-10ML - Milliliter0143-987241e97aa7-8705-4a99-8872-7e1bdc3ff7ab12018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPRANOLOL HYDROCHLORIDEACTIVE INGREDIENTF8A3652H1VPROPRANOLOL HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP]3
PROPRANOLOLACTIVE MOIETY9Y8NXQ24VQPROPRANOLOL HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROPRANOLOL HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP]3
WATERINACTIVE INGREDIENT059QF0KO0RPROPRANOLOL HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP]3
PROPRANOLOL HYDROCHLORIDEACTIVE INGREDIENTF8A3652H1VPROPRANOLOL (PROPRANOLOL) INJECTION [PHYSICIANS TOTAL CARE, INC.]1
PROPRANOLOLACTIVE MOIETY9Y8NXQ24VQPROPRANOLOL (PROPRANOLOL) INJECTION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9872PROPRANOLOL HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]6Current NDC, Legacy NDC, 2 package rows20220820_91f2ff1d-68d8-4e83-a2db-618f0410ead7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856443propranolol HCl 1 MG in 1 ML InjectionPSN7da73cee-4e98-462d-e053-2991aa0a8bf48
8564431 ML propranolol hydrochloride 1 MG/ML InjectionSCD7da73cee-4e98-462d-e053-2991aa0a8bf48
856443propranolol hydrochloride 1 MG per ML InjectionSY7da73cee-4e98-462d-e053-2991aa0a8bf48
856443propranolol HCl 1 MG in 1 ML InjectionPSN91f2ff1d-68d8-4e83-a2db-618f0410ead77
8564431 ML propranolol hydrochloride 1 MG/ML InjectionSCD91f2ff1d-68d8-4e83-a2db-618f0410ead77
856443propranolol hydrochloride 1 MG per ML InjectionSY91f2ff1d-68d8-4e83-a2db-618f0410ead77
856443propranolol HCl 1 MG in 1 ML InjectionPSN693569bd-6053-5b3e-e053-2a91aa0a6e9c3
8564431 ML propranolol hydrochloride 1 MG/ML InjectionSCD693569bd-6053-5b3e-e053-2a91aa0a6e9c3
856443propranolol hydrochloride 1 MG per ML InjectionSY693569bd-6053-5b3e-e053-2a91aa0a6e9c3
856443propranolol HCl 1 MG in 1 ML InjectionPSNd0a8c5d1-bfc1-4829-bbf4-609e05e6d25c1
8564431 ML propranolol hydrochloride 1 MG/ML InjectionSCDd0a8c5d1-bfc1-4829-bbf4-609e05e6d25c1
856443propranolol hydrochloride 1 MG per ML InjectionSYd0a8c5d1-bfc1-4829-bbf4-609e05e6d25c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9872-01001439872011 mL in 1 VIAL1 mlHistorical
0143-9872-100014398721010 VIAL in 1 CARTON (0143-9872-10) / 1 mL in 1 VIAL (0143-9872-01) 10 vial2008-01-310000-00-00NoNoCurrent