Prescription drug · ANDA
Lincomycin (Lincomycin hydrochloride) NDC 25021-193
Lincomycin hydrochloride 300 mg/mL · Injection, Solution · Intramuscular, Intravenous, Subconjunctival · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-193-02 | 25021019302 | 10 VIAL in 1 CARTON (25021-193-02) / 2 mL in 1 VIALMarketed from Apr 15, 2023 | |
| 25021-193-10 | 25021019310 | 10 VIAL in 1 CARTON (25021-193-10) / 10 mL in 1 VIALMarketed from Apr 15, 2023 |
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
- Generic name (nonproprietary)
- lincomycin hydrochloride
- Active ingredients
- Lincomycin hydrochloride — 300 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous, Subconjunctival
- Labeler
- Sagent PharmaceuticalsNDC labeler code 25021
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215657
- Marketing start
- Listing expires
- Identifiers
- Product ID 25021-193_36277638-639e-4141-9ad0-a5afaa12043bSPL ID 36277638-639e-4141-9ad0-a5afaa12043bSPL set ID 75e149cc-b668-427e-bae7-a0d215e4fb7aRxCUI 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.
- NDC on a medical claim
N425021019302followed by a unit qualifier and the quantityPackage 25021-0193-02. 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 . 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.
About NDC 25021-193
- What is NDC 25021-193?
- 25021-193 is the product NDC for Lincomycin (lincomycin hydrochloride), Lincomycin hydrochloride 300 mg/mL injection, solution, listed with the FDA by Sagent Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lincomycin (Lincomycin Hydrochloride).
- What is the active ingredient?
- Lincomycin hydrochloride.
- Who is the labeler?
- Sagent Pharmaceuticals, NDC labeler code 25021. 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?
- 9 other product NDCs are listed under this name. See all Lincomycin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lincomycin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lincomycinlincomycin hydrochloride | Lincomycin hydrochloride 3000 mg/10mL | InjectionIntramuscular, Intravenous | PAI Holdings, LLC dba PAI Pharma | 0121-1035 | 00121-1035-55 |
| Lincomycin | Lincomycin hydrochloride 600 mg/2mL | Injection, SolutionIntramuscular, Intravenous | Armas Pharmaceuticals Inc. | 72485-114 | 72485-0114-01 |
| Lincomycin | Lincomycin hydrochloride 3000 mg/10mL | Injection, SolutionIntramuscular, Intravenous | Armas Pharmaceuticals Inc. | 72485-115 | 72485-0115-10 |
| lincomycin | Lincomycin 300 mg/mL | Injection, SolutionIntramuscular, Intravenous | Slate Run Pharmaceuticals, LLC | 70436-034 | 70436-0034-82 |
| lincomycin | Lincomycin 300 mg/mL | Injection, SolutionIntramuscular, Intravenous | Slate Run Pharmaceuticals, LLC | 70436-035 | 70436-0035-8070436-0035-82 |
| Lincomycin | Lincomycin hydrochloride 300 mg/mL | Injection, SolutionIntramuscular, Intravenous | Micro Labs Limited | 42571-374 | 42571-0374-7542571-0374-8842571-0374-89+1 more |
| Lincomycinlincomycin hydrochloride | Lincomycin hydrochloride 300 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subconjunctival | Henry Schein, Inc. | 0404-9901 | 00404-9901-10 |
| Lincomycinlincomycin hydrochloride | Lincomycin hydrochloride 300 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subconjunctival | XGen Pharmaceuticals DJB, Inc. | 39822-0350 | 39822-0350-02 |
| Lincomycinlincomycin hydrochloride | Lincomycin hydrochloride 300 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subconjunctival | XGen Pharmaceuticals DJB, Inc. | 39822-0353 | 39822-0353-06 |
Other NDCs under ANDA 215657
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| lincomycin hydrochloride | Lincomycin hydrochloride 300 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subconjunctival | Gland Pharma Limited | 68083-478 |
| Lincomycin hydrochloride | Lincomycin hydrochloride 300 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subconjunctival | Gland Pharma Limited | 68083-479 |