Prescription drug · NDA
Ziana (Clindamycin phosphate and tretinoin) NDC 99207-300
Clindamycin phosphate 12 mg/g; Tretinoin .25 mg/g · Gel · Topical · Bausch Health US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 99207-300-30 | 9920703003099207030030 | 1 TUBE in 1 CARTON (99207-300-30) / 30 g in 1 TUBEMarketed from Dec 1, 2006 | |
| 99207-300-60 | 9920703006099207030060 | 1 TUBE in 1 CARTON (99207-300-60) / 60 g in 1 TUBEMarketed from Dec 1, 2006 |
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)
- Ziana
- Generic name (nonproprietary)
- clindamycin phosphate and tretinoin
- Active ingredients
- Clindamycin phosphate — 12 mg/gTretinoin — .25 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Bausch Health US, LLCNDC labeler code 99207
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 050802
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)Retinoids (Chemical structure)
- Identifiers
- Product ID 99207-300_d765377b-8dc9-4a8e-b063-9903eb4f2176SPL ID d765377b-8dc9-4a8e-b063-9903eb4f2176SPL set ID 78c329f9-f0c9-486d-9e54-0123699fb9e1RxCUI 882548, 882550UNII EH6D7113I8, 5688UTC01R
- Pharmacologic class
- Lincosamide Antibacterial; Retinoid
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
N499207030030followed by a unit qualifier and the quantityPackage 99207-0300-30. 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)
ZIANA Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. ZIANA ® Gel is a lincosamide antibiotic and retinoid combination product indicated for the topical treatment of acne vulgaris in patients 12 years or older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 99207-300
- What is NDC 99207-300?
- 99207-300 is the product NDC for Ziana, Clindamycin phosphate 12 mg/g; Tretinoin .25 mg/g gel, listed with the FDA by Bausch Health US, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ziana (Clindamycin phosphate and tretinoin).
- What is the active ingredient?
- Clindamycin phosphate, Tretinoin.
- Who is the labeler?
- Bausch Health US, LLC, NDC labeler code 99207. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ziana?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 050802
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 Phosphate 1.2% and Tretinoin 0.025%clindamycin phosphate and tretinoin | Clindamycin phosphate 12 mg/g; Tretinoin .25 mg/g | GelTopical | Oceanside Pharmaceuticals | 68682-300 |