MedPath

Doxycycline

Doxycycline Capsules USP

Approved
Approval ID

9c902015-bbbe-4a78-97c3-f66608d48f67

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 27, 2023

Manufacturers
FDA

REMEDYREPACK INC.

DUNS: 829572556

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

doxycycline

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70518-0187
Application NumberANDA065055
Product Classification
M
Marketing Category
C73584
G
Generic Name
doxycycline
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2023
FDA Product Classification

INGREDIENTS (12)

GELATINInactive
Code: 2G86QN327L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
DOXYCYCLINEActive
Quantity: 100 mg in 1 1
Code: N12000U13O
Classification: ACTIM
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT

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Doxycycline - FDA Drug Approval Details