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Doxycycline Hyclate

DOXYCYCLINE HYCLATE TABLETS, USP

Approved
Approval ID

49f82130-6f8a-412c-b625-e75906e74675

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 15, 2023

Manufacturers
FDA

Larken Laboratories, Inc.

DUNS: 149484540

Products 1

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 Code68047-714
Application NumberANDA065287
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxycycline Hyclate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification

INGREDIENTS (12)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
DOXYCYCLINE HYCLATEActive
Quantity: 20 mg in 1 1
Code: 19XTS3T51U
Classification: ACTIM

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Doxycycline Hyclate - FDA Drug Approval Details