FDA.reportPublic FDA data

Propranolol Hydrochloride

Product NDC
66267-261
Requested package NDC
66267-261-90
11-digit product format
662670261
Labeler code
66267
Product ID
66267-261_1fa6afe6-d920-02d3-e063-6394a90a41c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
propranolol hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA070217
Marketing category
ANDA
Marketing start
2010-06-21
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
2026-12-31
Current FDA listing
Yes

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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog.

Additional Listing Data#

Finished product
Yes
Brand name base
Propranolol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROPRANOLOL HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F8A3652H1VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856448Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92c4bd8f-d0e6-d11a-e053-2995a90a635dAvailable on FDA.report

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
66267-261-902024-08-14C16284748780-1f386c649-dbd1-0266-e053-dadaa90a7c1aPropranolol Hydrochloride Tablets, USP Rx only
66267-261-902023-01-30C16284748780-1f386c649-dbd1-0266-e053-dadaa90a7c1aPropranolol Hydrochloride Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-261-90Propranolol Hydrochloride90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-261PROPRANOLOL HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240815_92c4bd8f-d0e6-d11a-e053-2995a90a635d.zip

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
ndc (package): 66267-261-90
ndc (product): 66267-261
ndc11 (package): 66267026190

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856448propranolol HCl 10 MG Oral TabletPSN92c4bd8f-d0e6-d11a-e053-2995a90a635d3
856448propranolol hydrochloride 10 MG Oral TabletSCD92c4bd8f-d0e6-d11a-e053-2995a90a635d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-261-906626702619090 TABLET in 1 BOTTLE (66267-261-90) 90 tablet2019-09-170000-00-00NoNoCurrent