clonidine hydrochloride
Clonidine Hydrochloride Tablets USP
Approved
Approval ID
3d966e77-9331-4051-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2021
Manufacturers
FDA
NuCare Pharmaceuticals, Inc.
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
clonidine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66267-061
Application NumberANDA078895
Product Classification
M
Marketing Category
C73584
G
Generic Name
clonidine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 11, 2021
FDA Product Classification
INGREDIENTS (9)
CLONIDINE HYDROCHLORIDEActive
Quantity: 0.1 mg in 1 1
Code: W76I6XXF06
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT