FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
69292-536
11-digit product format
692920536
Labeler code
69292
Product ID
69292-536_ce606d4c-3af5-4274-b843-d8d8fe2c96ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propranolol Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AMICI PHARMACEUTICALS LLC
Application
ANDA070322
Marketing category
ANDA
Marketing start
2019-10-31
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
60 mg/1
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 HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF8A3652H1V
Rxcui856448, 856457, 856519, 856556, 856578

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
69292-536-01Propranolol Hydrochloride100 in 1 BOTTLETABLET1004
69292-536-10Propranolol Hydrochloride1000 in 1 BOTTLETABLET10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69292-536PROPRANOLOL HYDROCHLORIDE TABLET PROPRANOLOL HYDROCHLORIDE TABLET [AMICI PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 2 package rows20230125_8efc9fc6-6db0-43c9-892b-7423a9ba679f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSN8efc9fc6-6db0-43c9-892b-7423a9ba679f4
856457propranolol HCl 20 MG Oral TabletPSN8efc9fc6-6db0-43c9-892b-7423a9ba679f4
856519propranolol HCl 40 MG Oral TabletPSN8efc9fc6-6db0-43c9-892b-7423a9ba679f4
856556propranolol HCl 60 MG Oral TabletPSN8efc9fc6-6db0-43c9-892b-7423a9ba679f4
856578propranolol HCl 80 MG Oral TabletPSN8efc9fc6-6db0-43c9-892b-7423a9ba679f4
856448propranolol hydrochloride 10 MG Oral TabletSCD8efc9fc6-6db0-43c9-892b-7423a9ba679f4
856457propranolol hydrochloride 20 MG Oral TabletSCD8efc9fc6-6db0-43c9-892b-7423a9ba679f4
856519propranolol hydrochloride 40 MG Oral TabletSCD8efc9fc6-6db0-43c9-892b-7423a9ba679f4
856556propranolol hydrochloride 60 MG Oral TabletSCD8efc9fc6-6db0-43c9-892b-7423a9ba679f4
856578propranolol hydrochloride 80 MG Oral TabletSCD8efc9fc6-6db0-43c9-892b-7423a9ba679f4
856448propranolol HCl 10 MG Oral TabletPSNd08dbabc-8ca4-426e-a9fd-e7914a27883c1
856457propranolol HCl 20 MG Oral TabletPSNd08dbabc-8ca4-426e-a9fd-e7914a27883c1
856519propranolol HCl 40 MG Oral TabletPSNd08dbabc-8ca4-426e-a9fd-e7914a27883c1
856556propranolol HCl 60 MG Oral TabletPSNd08dbabc-8ca4-426e-a9fd-e7914a27883c1
856578propranolol HCl 80 MG Oral TabletPSNd08dbabc-8ca4-426e-a9fd-e7914a27883c1
856448propranolol hydrochloride 10 MG Oral TabletSCDd08dbabc-8ca4-426e-a9fd-e7914a27883c1
856457propranolol hydrochloride 20 MG Oral TabletSCDd08dbabc-8ca4-426e-a9fd-e7914a27883c1
856519propranolol hydrochloride 40 MG Oral TabletSCDd08dbabc-8ca4-426e-a9fd-e7914a27883c1
856556propranolol hydrochloride 60 MG Oral TabletSCDd08dbabc-8ca4-426e-a9fd-e7914a27883c1
856578propranolol hydrochloride 80 MG Oral TabletSCDd08dbabc-8ca4-426e-a9fd-e7914a27883c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69292-536-0169292053601100 TABLET in 1 BOTTLE (69292-536-01) 100 tablet2019-10-310000-00-00NoNoCurrent
69292-536-10692920536101000 TABLET in 1 BOTTLE (69292-536-10) 1000 tablet2019-10-310000-00-00NoNoCurrent