FDA.reportPublic FDA data

Clonidine hydrochloride

Product NDC
51655-962
11-digit product format
516550962
Labeler code
51655
Product ID
51655-962_4974a59a-10c1-4b0c-e063-6294a90af79b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA070924
Marketing category
ANDA
Marketing start
2022-04-15
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.2 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog.

Additional Listing Data#

Finished product
Yes
Brand name base
Clonidine hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE HYDROCHLORIDE.2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W76I6XXF06Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
884185Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
df77e732-9765-ee5c-e053-2a95a90abc92Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45c8ba14-e378-46f0-b21f-1aad8e08c613Product name120250221
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name920190618
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name520171212
48f5a4fd-7cdc-dc04-771d-ce7a47326789Product name220150123
624cf764-e200-44b5-83c2-84526255adb5Product name120150107
47972e1b-c905-eeee-5e77-eb4538ad833cProduct name120140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-962-52Clonidine hydrochloride30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-962CLONIDINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS]2Current NDC, Legacy NDC, 1 package rows20231219_df77e732-9765-ee5c-e053-2a95a90abc92.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEBryant Ranch Prepacka32f4b18-1090-4d79-a56b-39c0cf366bbc2026-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070924
application number: ANDA070924
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDENorthwind Health Company, LLCdf77e732-9765-ee5c-e053-2a95a90abc922026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070924
application number: ANDA070924
ndc (product): 51655-962
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEProficient Rx LP8427eee0-955d-4718-b259-73dab56d36d22023-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070924
application number: ANDA070924
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEAsclemed USA, Inc.e8c7aa08-1450-de68-e053-2995a90ad0b62022-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 070924
application number: ANDA070924

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884185cloNIDine HCl 0.2 MG Oral TabletPSNdf77e732-9765-ee5c-e053-2a95a90abc923
884185clonidine hydrochloride 0.2 MG Oral TabletSCDdf77e732-9765-ee5c-e053-2a95a90abc923
884185clonidine HCl 200 MCG Oral TabletSYdf77e732-9765-ee5c-e053-2a95a90abc923

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-962-525165509625230 TABLET in 1 BOTTLE, PLASTIC (51655-962-52) 30 tablet2022-04-150000-00-00NoNoCurrent