lincomycin hydrochloride

Generic: lincomycin hydrochloride

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

Drug Facts

Product Profile

Brand Name lincomycin hydrochloride
Generic Name lincomycin hydrochloride
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS SUBCONJUNCTIVAL
Active Ingredients

lincomycin hydrochloride 300 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-478
Product ID 68083-478_084e1826-51be-4e48-aae4-b6affb80853f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215657
Listing Expiration 2026-12-31
Marketing Start 2022-09-26

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083478
Hyphenated Format 68083-478

Supplemental Identifiers

RxCUI
239212
UNII
M6T05Z2B68

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 lincomycin hydrochloride (source: ndc)
Generic Name lincomycin hydrochloride (source: ndc)
Application Number ANDA215657 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS SUBCONJUNCTIVAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68083-478-01) / 2 mL in 1 VIAL
source: ndc

Packages (1)

68083-478-01 1 VIAL in 1 CARTON (68083-478-01) / 2 mL in 1 VIAL

Ingredients (1)

lincomycin hydrochloride (300 mg/mL)

Linked Drug Pages (1)

lincomycin hydrochloride, Lincomycin hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS", "SUBCONJUNCTIVAL"], "spl_id": "084e1826-51be-4e48-aae4-b6affb80853f", "openfda": {"unii": ["M6T05Z2B68"], "rxcui": ["239212"], "spl_set_id": ["c2b5be20-cc6f-4221-9d3e-3f8b5886cd05"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-478-01)  / 2 mL in 1 VIAL", "package_ndc": "68083-478-01", "marketing_start_date": "20220926"}], "brand_name": "lincomycin hydrochloride", "product_id": "68083-478_084e1826-51be-4e48-aae4-b6affb80853f", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "68083-478", "generic_name": "lincomycin hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lincomycin hydrochloride", "active_ingredients": [{"name": "LINCOMYCIN HYDROCHLORIDE", "strength": "300 mg/mL"}], "application_number": "ANDA215657", "marketing_category": "ANDA", "marketing_start_date": "20220926", "listing_expiration_date": "20261231"}