Propranolol Hydrochloride

Product NDC
50090-0146
11-digit product format
500900146
Labeler code
50090
Product ID
50090-0146_9e1c6f90-de2f-4213-8f9b-03fdab19b9b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA070217
Marketing category
ANDA
Marketing start
2010-06-21
Marketing end
0000-00-00
Substance
PROPRANOLOL HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-0146DDiscontinued by firm2026-10-05
excluded packagepackage50090-014650090-0146-0DDiscontinued by firm2026-10-05
excluded packagepackage50090-014650090-0146-1DDiscontinued by firm2026-10-05
excluded packagepackage50090-014650090-0146-2DDiscontinued by firm2026-10-05
excluded packagepackage50090-014650090-0146-5DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-0146-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-0146-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-0146-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-0146-5d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-0146-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-0146-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-0146-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-0146-5f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0146-1EA - Each50090-01460e51850a-f282-4306-8917-889ebea022db12018-08-13
50090-0146-5EA - Each50090-0146f6211e21-2bc6-458b-9510-b315a7f7141c12021-05-05

DailyMed Socrata Ingredients#

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROPRANOLOL HYDROCHLORIDEPROPRANOLOL HYDROCHLORIDEDIRECT RXa834d1cf-72fc-93bf-e053-2995a90a61912025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070217
application number: ANDA070217
Propranolol HydrochloridePROPRANOLOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.92c4bd8f-d0e6-d11a-e053-2995a90a635d2024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070217
application number: ANDA070217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0146-150090014601100 TABLET in 1 BOTTLE (50090-0146-1) 100 tablet2014-11-280000-00-00NoNoCurrent
50090-0146-55009001460590 TABLET in 1 BOTTLE (50090-0146-5) 90 tablet2019-07-050000-00-00NoNoCurrent