doxycycline hyclate

Generic: doxycycline hyclate

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name doxycycline hyclate
Generic Name doxycycline hyclate
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

doxycycline hyclate 100 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-353
Product ID 46708-353_8a6d5c0f-9b8e-444e-882e-8a2264410c02
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210536
Listing Expiration 2026-12-31
Marketing Start 2020-05-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708353
Hyphenated Format 46708-353

Supplemental Identifiers

RxCUI
1650143 1652674
UPC
0346708353209 0346708499600
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 hyclate (source: ndc)
Generic Name doxycycline hyclate (source: ndc)
Application Number ANDA210536 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (46708-353-20)
  • 50 TABLET, FILM COATED in 1 BOTTLE (46708-353-50)
  • 500 TABLET, FILM COATED in 1 BOTTLE (46708-353-71)
source: ndc

Packages (3)

46708-353-20 20 TABLET, FILM COATED in 1 BOTTLE (46708-353-20) 46708-353-50 50 TABLET, FILM COATED in 1 BOTTLE (46708-353-50) 46708-353-71 500 TABLET, FILM COATED in 1 BOTTLE (46708-353-71)

Ingredients (1)

doxycycline hyclate (100 mg/1)

Linked Drug Pages (1)

Doxycycline Hyclate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8a6d5c0f-9b8e-444e-882e-8a2264410c02", "openfda": {"upc": ["0346708353209", "0346708499600"], "unii": ["19XTS3T51U"], "rxcui": ["1650143", "1652674"], "spl_set_id": ["24c8472a-dd07-4f84-8bea-20a3f178d119"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (46708-353-20)", "package_ndc": "46708-353-20", "marketing_start_date": "20200515"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (46708-353-50)", "package_ndc": "46708-353-50", "marketing_start_date": "20200515"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (46708-353-71)", "package_ndc": "46708-353-71", "marketing_start_date": "20200515"}], "brand_name": "Doxycycline Hyclate", "product_id": "46708-353_8a6d5c0f-9b8e-444e-882e-8a2264410c02", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Tetracycline-class Drug [EPC]", "Tetracyclines [CS]"], "product_ndc": "46708-353", "generic_name": "Doxycycline Hyclate", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Doxycycline Hyclate", "active_ingredients": [{"name": "DOXYCYCLINE HYCLATE", "strength": "100 mg/1"}], "application_number": "ANDA210536", "marketing_category": "ANDA", "marketing_start_date": "20200515", "listing_expiration_date": "20261231"}