FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
0121-0908
11-digit product format
001210908
Labeler code
0121
Product ID
0121-0908_e20b8c76-152c-9fee-e053-2a95a90aa52d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA070979
Marketing category
ANDA
Marketing start
2021-09-03
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

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
0121-0908-05Propranolol Hydrochloride5 mL in 1 CUP, UNIT-DOSESOLUTION54
0121-0908-40Propranolol Hydrochloride4 in 1 CASESOLUTION44
0121-0908-40Propranolol Hydrochloride10 in 1 TRAYSOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0908-05ML - Milliliter0121-09080c98026a-2ac3-4103-8296-2687f42991fd12021-11-09
0121-0908-40ML - Milliliter0121-09080dec7d61-3033-478b-be0a-d4c02acfe3ba12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0908PROPRANOLOL HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4Current NDC, Legacy NDC, 3 package rows20220624_ec5c919b-05d1-45d2-a6e4-ac4ae1101dbb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0908-05001210908055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0121-0908-40001210908404 TRAY in 1 CASE (0121-0908-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0908-05) 4 tray2021-09-030000-00-00NoNoCurrent