What is NDC 68083-478?

68083-478 is the product NDC for lincomycin hydrochloride, Lincomycin hydrochloride 300 mg/mL injection, solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for lincomycin hydrochloride?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

lincomycin hydrochloride NDC 68083-478

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-478Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0478Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
68083-478-01	68083047801	1 VIAL in 1 CARTON (68083-478-01) / 2 mL in 1 VIALMarketed from Sep 26, 2022

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): lincomycin hydrochloride
Generic name (nonproprietary): lincomycin hydrochloride
Active ingredients: Lincomycin hydrochloride — 300 mg/mL
Dosage form: Injection, Solution
Route: Intramuscular, Intravenous, Subconjunctival
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215657
Marketing start: Sep 26, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 68083-478_084e1826-51be-4e48-aae4-b6affb80853fSPL ID 084e1826-51be-4e48-aae4-b6affb80853fSPL set ID c2b5be20-cc6f-4221-9d3e-3f8b5886cd05RxCUI 239212UNII M6T05Z2B68

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N468083047801 followed by a unit qualifier and the quantity

Package 68083-0478-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Sep 28, 2022. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Lincomycin injection is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the BOXED WARNING , before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy. Lincomycin injection may be administered concomitantly with other antimicrobial agents wh…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-478

What is NDC 68083-478?: 68083-478 is the product NDC for lincomycin hydrochloride, Lincomycin hydrochloride 300 mg/mL injection, solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: lincomycin hydrochloride.
What is the active ingredient?: Lincomycin hydrochloride.
Who is the labeler?: Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for lincomycin hydrochloride?: 1 other product NDC are listed under this name. See all lincomycin hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other lincomycin hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Lincomycin hydrochloride	Lincomycin hydrochloride 300 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subconjunctival	Gland Pharma Limited	68083-479	68083-0479-01

Other NDCs under ANDA 215657

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 215657
Product	Strength	Form · route	Labeler	Product NDC
Lincomycinlincomycin hydrochloride	Lincomycin hydrochloride 300 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subconjunctival	Sagent Pharmaceuticals	25021-193
Lincomycin hydrochloride	Lincomycin hydrochloride 300 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subconjunctival	Gland Pharma Limited	68083-479