PROPRANOLOL

Product NDC
0404-9999
11-digit product format
004049999
Labeler code
0404
Product ID
0404-9999_a64c6dcb-7a81-4f7e-bd26-7ca72c56003b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA075826
Marketing category
ANDA
Marketing start
2024-07-15
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
0404-9999-01PROPRANOLOL1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION12
0404-9999-01PROPRANOLOL1 in 1 BAGINJECTION, SOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9999PROPRANOLOL (PROPRANOLOL HYDROCHLORIDE) INJECTION, SOLUTION [HENRY SCHEIN, INC.]1Current NDC, 2 package rows20240808_e586996d-9035-4ef4-8c8d-06e70a02577f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856443propranolol HCl 1 MG in 1 ML InjectionPSNe586996d-9035-4ef4-8c8d-06e70a02577f2
8564431 ML propranolol hydrochloride 1 MG/ML InjectionSCDe586996d-9035-4ef4-8c8d-06e70a02577f2
856443propranolol hydrochloride 1 MG per ML InjectionSYe586996d-9035-4ef4-8c8d-06e70a02577f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0404-9999-01004049999011 VIAL, SINGLE-DOSE in 1 BAG (0404-9999-01) / 1 mL in 1 VIAL, SINGLE-DOSE2024-07-15NoNoCurrent