MedPath

Doxycycline Hyclate

Doxycycline Hyclate Capsules, USP

Approved
Approval ID

ccf9708a-ed3b-4786-b3a6-e96125b2f9d5

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 18, 2021

Manufacturers
FDA

Zhejiang Yongtai Pharmaceutical Co., Ltd

DUNS: 544302778

Products 2

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

Doxycycline Hyclate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69434-017
Application NumberANDA212610
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxycycline Hyclate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 18, 2021
FDA Product Classification

INGREDIENTS (6)

Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
DOXYCYCLINE HYCLATEActive
Quantity: 100 mg in 1 1
Code: 19XTS3T51U
Classification: ACTIM
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT

Doxycycline Hyclate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69434-016
Application NumberANDA212610
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxycycline Hyclate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 18, 2021
FDA Product Classification

INGREDIENTS (6)

TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DOXYCYCLINE HYCLATEActive
Quantity: 50 mg in 1 1
Code: 19XTS3T51U
Classification: ACTIM
Microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT

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Doxycycline Hyclate - FDA Drug Approval Details