demeclocycline hydrochloride

Generic: demeclocycline

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name demeclocycline hydrochloride
Generic Name demeclocycline
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

demeclocycline hydrochloride 300 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-555
Product ID 53746-555_bd37276e-8e9f-48ec-9565-a83a5a4f9aea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065425
Listing Expiration 2026-12-31
Marketing Start 2022-05-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53746555
Hyphenated Format 53746-555

Supplemental Identifiers

RxCUI
905341 905347
UPC
0353746554017 0353746555489
UNII
29O079NTYT

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 demeclocycline hydrochloride (source: ndc)
Generic Name demeclocycline (source: ndc)
Application Number ANDA065425 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 48 TABLET in 1 BOTTLE (53746-555-48)
source: ndc

Packages (1)

53746-555-48 48 TABLET in 1 BOTTLE (53746-555-48)

Ingredients (1)

demeclocycline hydrochloride (300 mg/1)

Linked Drug Pages (1)

Demeclocycline Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bd37276e-8e9f-48ec-9565-a83a5a4f9aea", "openfda": {"upc": ["0353746554017", "0353746555489"], "unii": ["29O079NTYT"], "rxcui": ["905341", "905347"], "spl_set_id": ["539add06-e0a0-401a-b4f6-20776084aa9c"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "48 TABLET in 1 BOTTLE (53746-555-48)", "package_ndc": "53746-555-48", "marketing_start_date": "20220525"}], "brand_name": "Demeclocycline Hydrochloride", "product_id": "53746-555_bd37276e-8e9f-48ec-9565-a83a5a4f9aea", "dosage_form": "TABLET", "pharm_class": ["Tetracycline-class Antimicrobial [EPC]", "Tetracyclines [CS]"], "product_ndc": "53746-555", "generic_name": "Demeclocycline", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Demeclocycline Hydrochloride", "active_ingredients": [{"name": "DEMECLOCYCLINE HYDROCHLORIDE", "strength": "300 mg/1"}], "application_number": "ANDA065425", "marketing_category": "ANDA", "marketing_start_date": "20220525", "listing_expiration_date": "20261231"}