NDC codes

FDA NDC Directory
Product NDC (as listed)99207-300Labeler and product segments. Claims need a package NDC.
Product NDC at billing width99207-0300Add 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 NDC11-digit (billing)PackageCopy
99207-300-3099207030030992070300301 TUBE in 1 CARTON (99207-300-30) / 30 g in 1 TUBEMarketed from Dec 1, 2006
99207-300-6099207030060992070300601 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

N499207030030 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under NDA 050802
ProductStrengthForm · routeLabelerProduct NDC
Clindamycin Phosphate 1.2% and Tretinoin 0.025%clindamycin phosphate and tretinoinClindamycin phosphate 12 mg/g; Tretinoin .25 mg/gGelTopicalOceanside Pharmaceuticals68682-300

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