What is NDC 0168-0201?

0168-0201 is the product NDC for clindamycin phosphate, Clindamycin phosphate 10 mg/mL solution, listed with the FDA by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, NDC labeler code 0168. 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 phosphate?

70 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

clindamycin phosphate NDC 0168-0201

NDC codes

FDA NDC Directory

Product NDC (as listed)0168-0201Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00168-0201Add 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 NDC	11-digit (billing)	Package	Copy
0168-0201-30	0016802013000168020130	1 BOTTLE in 1 CARTON (0168-0201-30) / 30 mL in 1 BOTTLEMarketed from Jun 5, 1997
0168-0201-60	0016802016000168020160	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
Labeler: E. Fougera & Co. a division of Fougera Pharmaceuticals, LLCNDC labeler code 0168
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 064159
Marketing start: Jun 5, 1997
Listing expires: Dec 31, 2027
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

N400168020130 followed by a unit qualifier and the quantity

Package 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 Jan 28, 2026.

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.

Full label on DailyMed (opens in a new tab)

About NDC 0168-0201

What is NDC 0168-0201?: 0168-0201 is the product NDC for clindamycin phosphate, Clindamycin phosphate 10 mg/mL solution, listed with the FDA by E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: clindamycin phosphate.
What is the active ingredient?: Clindamycin phosphate.
Who is the labeler?: E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, NDC labeler code 0168. 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 phosphate?: 70 other product NDCs are listed under this name. See all clindamycin phosphate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other clindamycin phosphate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Clindamycin Phosphate	Clindamycin phosphate 10 mg/mL	SolutionTopical	Rising Pharma Holdings, Inc.	16571-256	16571-0256-6016571-0256-69
Clindamycin Phosphate	Clindamycin phosphate 10 mg/g	GelTopical	Aurobindo Pharma Limited	59651-806	59651-0806-3059651-0806-60
Clindamycin Phosphateclindamycin phosphate topical	Clindamycin phosphate 10 mg/mL	SolutionTopical	Carnegie Pharmaceuticals, LLC	80005-131	80005-0131-0980005-0131-38
Clindamycin phosphateclindamycin phosphate topical	Clindamycin phosphate 10 mg/mL	SolutionTopical	i3 Pharmaceuticals, LLC	72319-696	72319-0696-60
Clindamycin Phosphate	Clindamycin phosphate 10 mg/g	GelTopical	Solaris Pharma Corporation	73473-300	73473-0300-3073473-0300-60
Clindamycin Phosphate	Clindamycin phosphate 1 g/10mL	GelTopical	Solaris Pharma Corporation	73473-302	73473-0302-75
Clindamycin Phosphate	Clindamycin phosphate 10 mg/g	GelTopical	Alembic Pharmaceuticals Limited	46708-623	46708-0623-3046708-0623-60
Clindamycin Phosphate	Clindamycin phosphate 10 mg/g	GelTopical	Alembic Pharmaceuticals Inc.	62332-623	62332-0623-3062332-0623-60
Clindamycin Phosphate	Clindamycin phosphate 10 mg/g	Aerosol, FoamTopical	GLENMARK PHARMACEUTICALS INC., USA	68462-605	68462-0605-2768462-0605-94
Clindamycin Phosphate	Clindamycin phosphate 10 mg/g	GelTopical	Viona Pharmaceuticals Inc	72578-118	72578-0118-0172578-0118-02

All 71 clindamycin phosphate NDCs