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