What is NDC 45802-042?

45802-042 is the product NDC for Clindesse (clindamycin phosphate), Clindamycin phosphate 100 mg/5g cream, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Clindesse (Clindamycin phosphate).

Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Clindesse?

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.

Clindesse NDC 45802-042 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)45802-042Labeler and product segments. Claims need a package NDC.

Product NDC at billing width45802-0042Add 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
45802-042-01	4580200420145802004201	1 APPLICATOR in 1 CARTON (45802-042-01) / 5 g in 1 APPLICATORMarketed from Jul 3, 2015
45802-042-02	4580200420245802004202	1 APPLICATOR in 1 CARTON (45802-042-02) / 5 g in 1 APPLICATORMarketed from Jul 3, 2015 · Sample package

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): Clindesse
Generic name (nonproprietary): clindamycin phosphate
Active ingredients: Clindamycin phosphate — 100 mg/5g
Dosage form: Cream
Route: Vaginal
Labeler: Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 050793
Marketing start: Jul 3, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers: Product ID 45802-042_ab0a6fe2-5ee0-408c-9e1d-30ce29344d16SPL ID ab0a6fe2-5ee0-408c-9e1d-30ce29344d16SPL set ID fe8bb204-f173-44fe-803b-b08f2ec5aa31RxCUI 309337, 602427UNII 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 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.

NDC on a medical claim

N445802004201 followed by a unit qualifier and the quantity

Package 45802-0042-01. 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 30, 2025.

Indications (excerpt from the label)

Clindesse is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in non-pregnant women ( 1.1 ) 1.1 Treatment of Bacterial Vaginosis Clindesse is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in non-pregnant women.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 45802-042

What is NDC 45802-042?: 45802-042 is the product NDC for Clindesse (clindamycin phosphate), Clindamycin phosphate 100 mg/5g cream, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Clindesse (Clindamycin phosphate).
What is the active ingredient?: Clindamycin phosphate.
Who is the labeler?: Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Clindesse?: 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.

Clindesse (Clindamycin phosphate) NDC 45802-042