Prescription drug · ANDA
clindamycin phosphate NDC 0168-0201
Clindamycin phosphate 10 mg/mL · Solution · Topical · E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0168-0201-30 | 00168020130 | 1 BOTTLE in 1 CARTON (0168-0201-30) / 30 mL in 1 BOTTLEMarketed from Jun 5, 1997 | |
| 0168-0201-60 | 00168020160 | 1 BOTTLE in 1 CARTON (0168-0201-60) / 60 mL in 1 BOTTLEMarketed from Jun 5, 1997 |
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 phosphate
- Generic name (nonproprietary)
- clindamycin phosphate
- Active ingredients
- Clindamycin phosphate — 10 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 064159
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 0168-0201_cb48e014-0b84-4c84-867e-50c0f698340dSPL ID cb48e014-0b84-4c84-867e-50c0f698340dSPL set ID 62a2019f-7410-4251-95ed-181925ade6e4RxCUI 197519, 309333, 2676585UNII EH6D7113I8
- 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 HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400168020130followed by a unit qualifier and the quantityPackage 00168-0201-30. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Clindamycin Phosphate Topical Solution, Clindamycin Phosphate Gel, and Clindamycin Phosphate Topical Lotion are indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS , WARNINGS and ADVERSE REACTIONS ).
Excerpt only. Read the full label for complete information.