FDA.reportPublic FDA data

Propranolol

Product NDC
63323-604
11-digit product format
633230604
Labeler code
63323
Product ID
63323-604_505851c4-b18c-4cd7-805c-4e923cc1fa7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROPRANOLOL HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA075826
Marketing category
ANDA
Marketing start
2001-09-07
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Propranolol
Listing expiration
2026-12-31

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
63323-604-01Propranolol10 in 1 TRAYINJECTION, SOLUTION104
63323-604-01Propranolol1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-604-01ML - Milliliter63323-604512f7711-5742-4c56-8ff3-f831e1f7a43e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROPRANOLOL HYDROCHLORIDEACTIVE INGREDIENTF8A3652H1VPROPRANOLOL (PROPRANOLOL HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
PROPRANOLOLACTIVE MOIETY9Y8NXQ24VQPROPRANOLOL (PROPRANOLOL HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPROPRANOLOL (PROPRANOLOL HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-604PROPRANOLOL (PROPRANOLOL HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]4Current NDC, Legacy NDC, 2 package rows20230119_f14ea537-dd5c-4c78-9037-9a85e9e610ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856443propranolol HCl 1 MG in 1 ML InjectionPSNf14ea537-dd5c-4c78-9037-9a85e9e610ef4
8564431 ML propranolol hydrochloride 1 MG/ML InjectionSCDf14ea537-dd5c-4c78-9037-9a85e9e610ef4
856443propranolol hydrochloride 1 MG per ML InjectionSYf14ea537-dd5c-4c78-9037-9a85e9e610ef4
856443propranolol HCl 1 MG in 1 ML InjectionPSN9e50d1ee-b7f3-e549-e053-2995a90a4a862
856443propranolol HCl 1 MG in 1 ML InjectionPSNe586996d-9035-4ef4-8c8d-06e70a02577f2
8564431 ML propranolol hydrochloride 1 MG/ML InjectionSCD9e50d1ee-b7f3-e549-e053-2995a90a4a862
8564431 ML propranolol hydrochloride 1 MG/ML InjectionSCDe586996d-9035-4ef4-8c8d-06e70a02577f2
856443propranolol hydrochloride 1 MG per ML InjectionSY9e50d1ee-b7f3-e549-e053-2995a90a4a862
856443propranolol hydrochloride 1 MG per ML InjectionSYe586996d-9035-4ef4-8c8d-06e70a02577f2
856443propranolol HCl 1 MG in 1 ML InjectionPSN45b0aaf0-df6c-7db0-e063-6294a90a91351
8564431 ML propranolol hydrochloride 1 MG/ML InjectionSCD45b0aaf0-df6c-7db0-e063-6294a90a91351
856443propranolol hydrochloride 1 MG per ML InjectionSY45b0aaf0-df6c-7db0-e063-6294a90a91351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63323-604-016332306040110 VIAL, SINGLE-DOSE in 1 TRAY (63323-604-01) / 1 mL in 1 VIAL, SINGLE-DOSE2001-09-070000-00-00NoNoCurrent