doxycycline hyclate

Generic: doxycycline hyclate

Labeler: slate run pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxycycline hyclate
Generic Name doxycycline hyclate
Labeler slate run pharmaceuticals, llc
Dosage Form POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

doxycycline anhydrous 200 mg/20mL

Manufacturer
Slate Run Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 70436-201
Product ID 70436-201_3c36af25-61de-f322-e063-6394a90ab704
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217685
Listing Expiration 2026-12-31
Marketing Start 2024-07-22

Pharmacologic Class

Established (EPC)
tetracycline-class drug [epc]
Chemical Structure
tetracyclines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70436201
Hyphenated Format 70436-201

Supplemental Identifiers

UNII
334895S862
NUI
N0000175882 M0021223

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 hyclate (source: ndc)
Generic Name doxycycline hyclate (source: ndc)
Application Number ANDA217685 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/20mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-201-82) / 20 mL in 1 VIAL, SINGLE-DOSE (70436-201-36)
source: ndc

Packages (1)

70436-201-82 10 VIAL, SINGLE-DOSE in 1 CARTON (70436-201-82) / 20 mL in 1 VIAL, SINGLE-DOSE (70436-201-36)

Ingredients (1)

doxycycline anhydrous (200 mg/20mL)

Linked Drug Pages (1)

doxycycline hyclate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3c36af25-61de-f322-e063-6394a90ab704", "openfda": {"nui": ["N0000175882", "M0021223"], "unii": ["334895S862"], "spl_set_id": ["f31e69fc-e513-40e4-91b5-22ccf1ed9437"], "pharm_class_cs": ["Tetracyclines [CS]"], "pharm_class_epc": ["Tetracycline-class Drug [EPC]"], "manufacturer_name": ["Slate Run Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (70436-201-82)  / 20 mL in 1 VIAL, SINGLE-DOSE (70436-201-36)", "package_ndc": "70436-201-82", "marketing_start_date": "20240722"}], "brand_name": "doxycycline hyclate", "product_id": "70436-201_3c36af25-61de-f322-e063-6394a90ab704", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Tetracycline-class Drug [EPC]", "Tetracyclines [CS]"], "product_ndc": "70436-201", "generic_name": "doxycycline hyclate", "labeler_name": "Slate Run Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "doxycycline hyclate", "active_ingredients": [{"name": "DOXYCYCLINE ANHYDROUS", "strength": "200 mg/20mL"}], "application_number": "ANDA217685", "marketing_category": "ANDA", "marketing_start_date": "20240722", "listing_expiration_date": "20261231"}