doxycycline

Generic: doxycycline

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxycycline
Generic Name doxycycline
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

doxycycline hyclate 100 mg/10mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-481
Product ID 68083-481_ca2211dc-d46a-4069-8aa3-a146475427a2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215583
Listing Expiration 2026-12-31
Marketing Start 2023-04-12

Pharmacologic Class

Classes
tetracycline-class drug [epc] tetracyclines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083481
Hyphenated Format 68083-481

Supplemental Identifiers

RxCUI
310027
UNII
19XTS3T51U

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name doxycycline (source: ndc)
Generic Name doxycycline (source: ndc)
Application Number ANDA215583 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/10mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (68083-481-10) / 10 mL in 1 VIAL
source: ndc

Packages (1)

68083-481-10 10 VIAL in 1 CARTON (68083-481-10) / 10 mL in 1 VIAL

Ingredients (1)

doxycycline hyclate (100 mg/10mL)

Linked Drug Pages (1)

DOXYCYCLINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ca2211dc-d46a-4069-8aa3-a146475427a2", "openfda": {"unii": ["19XTS3T51U"], "rxcui": ["310027"], "spl_set_id": ["6a5780a9-4548-427c-972a-ef49fdcbc84d"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (68083-481-10)  / 10 mL in 1 VIAL", "package_ndc": "68083-481-10", "marketing_start_date": "20230412"}], "brand_name": "DOXYCYCLINE", "product_id": "68083-481_ca2211dc-d46a-4069-8aa3-a146475427a2", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Tetracycline-class Drug [EPC]", "Tetracyclines [CS]"], "product_ndc": "68083-481", "generic_name": "DOXYCYCLINE", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DOXYCYCLINE", "active_ingredients": [{"name": "DOXYCYCLINE HYCLATE", "strength": "100 mg/10mL"}], "application_number": "ANDA215583", "marketing_category": "ANDA", "marketing_start_date": "20230412", "listing_expiration_date": "20261231"}