Prescription drug · ANDA
Clindamycin in 5 Percent Dextrose NDC 0781-3290
Clindamycin 18 mg/mL · Injection, Solution · Intravenous · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-3290-09 | 00781329009 | 24 BAG in 1 CARTON (0781-3290-09) / 50 mL in 1 BAG (0781-3290-91)Marketed from Feb 7, 2013 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Clindamycin in 5 Percent Dextrose
- Generic name (nonproprietary)
- clindamycin in 5 percent dextrose
- Active ingredients
- Clindamycin — 18 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201692
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 0781-3290_b553b8ab-ef4d-40ae-a5fb-a6242f2ad30aSPL ID b553b8ab-ef4d-40ae-a5fb-a6242f2ad30aSPL set ID 231d95a6-5e5f-4a45-a92b-d3d16ef0a7caRxCUI 309335, 309336, 309339UNII 3U02EL437C
- Pharmacologic class
- Lincosamide Antibacterial
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
N400781329009followed by a unit qualifier and the quantityPackage 00781-3290-09. 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 Clindamycin in 5% Dextrose Injection is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin in 5% Dextrose Injection is also 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 antibacterial drug-associated pseudomembranous colitis, as described in the BOXED WARNING , before selecting clindamycin the physician should consider the nature of the infection and the suitability of…
Excerpt only. Read the full label for complete information.
About NDC 0781-3290
- What is NDC 0781-3290?
- 0781-3290 is the product NDC for Clindamycin in 5 Percent Dextrose, Clindamycin 18 mg/mL injection, solution, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clindamycin in 5 Percent Dextrose.
- What is the active ingredient?
- Clindamycin.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Clindamycin in 5 Percent Dextrose?
- 7 other product NDCs are listed under this name. See all Clindamycin in 5 Percent Dextrose NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clindamycin in 5 Percent Dextrose products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clindamycin in 5 percent Dextroseclindamycin in percent dextrose | Clindamycin 6 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9267 | 00143-9267-01 |
| Clindamycin in 5 percent Dextrose | Clindamycin 12 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9268 | 00143-9268-01 |
| Clindamycin in 5 percent Dextrose | Clindamycin 18 mg/mL | Injection, SolutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9269 | 00143-9269-01 |
| Clindamycin in 5 Percent Dextrose | Clindamycin 12 mg/mL | Injection, SolutionIntravenous | Civica, Inc. | 72572-074 | 72572-0074-24 |
| Clindamycin in 5 Percent Dextrose | Clindamycin 18 mg/mL | Injection, SolutionIntravenous | Civica, Inc. | 72572-076 | 72572-0076-24 |
| Clindamycin in 5 Percent Dextrose | Clindamycin 6 mg/mL | Injection, SolutionIntravenous | Sandoz Inc | 0781-3288 | 00781-3288-09 |
| Clindamycin in 5 Percent Dextrose | Clindamycin 12 mg/mL | Injection, SolutionIntravenous | Sandoz Inc | 0781-3289 | 00781-3289-09 |
Other NDCs under ANDA 201692
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 |
|---|---|---|---|---|
| Clindamycin in 5 Percent Dextrose | Clindamycin 6 mg/mL | Injection, SolutionIntravenous | Sandoz Inc | 0781-3288 |
| Clindamycin in 5 Percent Dextrose | Clindamycin 12 mg/mL | Injection, SolutionIntravenous | Sandoz Inc | 0781-3289 |
| Clindamycin in 5 Percent Dextrose | Clindamycin 12 mg/mL | Injection, SolutionIntravenous | Civica, Inc. | 72572-074 |
| Clindamycin in 5 Percent Dextrose | Clindamycin 18 mg/mL | Injection, SolutionIntravenous | Civica, Inc. | 72572-076 |