FDA.reportPublic FDA data

PROPRANOLOL HYDROCHLORIDE

Product NDC
51662-1338
11-digit product format
516621338
Labeler code
51662
Product ID
51662-1338_37b5006f-2441-f90b-e063-6294a90abb12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROPRANOLOL HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA077760
Marketing category
ANDA
Marketing start
2018-12-22
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 HYDROCHLORIDE
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51662-1338-12020-02-07C16284748780-19d75b9d0-9904-f424-e053-dadaa90a57cePROPRANOLOL HYDROCHLORIDE INJECTION, USP 1mg/mL 1mL VIAL
51662-1338-12020-01-31C16284748780-19d75b9d0-9904-f424-e053-dadaa90a57cePROPRANOLOL HYDROCHLORIDE INJECTION, USP 1mg/mL 1mL VIAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1338-1PROPRANOLOL HYDROCHLORIDE1 mL in 1 VIALINJECTION18
51662-1338-2PROPRANOLOL HYDROCHLORIDE1 in 1 POUCHINJECTION18
51662-1338-2PROPRANOLOL HYDROCHLORIDE1 mL in 1 VIALINJECTION18
51662-1338-3PROPRANOLOL HYDROCHLORIDE10 in 1 CASEINJECTION108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1338PROPRANOLOL HYDROCHLORIDE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]7Current NDC, Legacy NDC, 4 package rows20240517_7da73cee-4e98-462d-e053-2991aa0a8bf4.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1338-1516621338011 mL in 1 VIAL (51662-1338-1) 1 ml2018-12-220000-00-00NoNoCurrent
51662-1338-2516621338021 in 1 POUCHHistorical
51662-1338-35166213380310 POUCH in 1 CASE (51662-1338-3) / 1 VIAL in 1 POUCH (51662-1338-2) / 1 mL in 1 VIAL10 pouch2022-10-010000-00-00NoNoCurrent