MedPath

Doxycycline

DOXYCYCLINE TABLETS, USP Rx only

Approved
Approval ID

30246241-a757-49fe-9cae-8b75aab54296

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 19, 2022

Manufacturers
FDA

Lake Erie Medical DBA Quality Care Products LLC

DUNS: 831276758

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 Code55700-122
Application NumberANDA091605
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxycycline
Product Specifications
Route of AdministrationORAL
Effective DateMarch 12, 2019
FDA Product Classification

INGREDIENTS (12)

HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
DOXYCYCLINEActive
Quantity: 100 mg in 1 1
Code: N12000U13O
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT

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Doxycycline - FDA Drug Approval Details