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, DELAYED RELEASE
Routes
ORAL
Active Ingredients

doxycycline hyclate 200 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-484
Product ID 46708-484_e1387662-e286-469d-b85f-60344918a17b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213075
Listing Expiration 2026-12-31
Marketing Start 2022-01-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708484
Hyphenated Format 46708-484

Supplemental Identifiers

RxCUI
406524 434018 799048 1423080
UPC
0346708483609 0346708482602 0346708481605 0346708484606
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 ANDA213075 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-484-30)
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-484-31)
  • 60 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-484-60)
  • 500 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-484-71)
source: ndc

Packages (4)

46708-484-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-484-30) 46708-484-31 100 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-484-31) 46708-484-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-484-60) 46708-484-71 500 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-484-71)

Ingredients (1)

doxycycline hyclate (200 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": "e1387662-e286-469d-b85f-60344918a17b", "openfda": {"upc": ["0346708483609", "0346708482602", "0346708481605", "0346708484606"], "unii": ["19XTS3T51U"], "rxcui": ["406524", "434018", "799048", "1423080"], "spl_set_id": ["44ac5de1-c0c6-4d58-9a49-b2dae60ea921"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-484-30)", "package_ndc": "46708-484-30", "marketing_start_date": "20221015"}, {"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-484-31)", "package_ndc": "46708-484-31", "marketing_start_date": "20220104"}, {"sample": false, "description": "60 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-484-60)", "package_ndc": "46708-484-60", "marketing_start_date": "20220104"}, {"sample": false, "description": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (46708-484-71)", "package_ndc": "46708-484-71", "marketing_start_date": "20220104"}], "brand_name": "Doxycycline Hyclate", "product_id": "46708-484_e1387662-e286-469d-b85f-60344918a17b", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Tetracycline-class Drug [EPC]", "Tetracyclines [CS]"], "product_ndc": "46708-484", "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": "200 mg/1"}], "application_number": "ANDA213075", "marketing_category": "ANDA", "marketing_start_date": "20220104", "listing_expiration_date": "20261231"}