Prescription drug · ANDA
clindamycin and benzoyl peroxide NDC 45802-509
Kit · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-509-01 | 4580205090145802050901 | 1 KIT in 1 CARTON (45802-509-01) * .3 g in 1 VIAL (45802-737-01) * 19.7 g in 1 JAR (45802-997-01)Marketed from Feb 3, 2021 |
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)
- clindamycin and benzoyl peroxide
- Generic name (nonproprietary)
- clindamycin and benzoyl peroxide
- Dosage form
- Kit
- Labeler
- Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202440
- Marketing start
- Listing expires
- Identifiers
- Product ID 45802-509_bae79e41-1b56-4bcc-9635-ffcf85fa0fdeSPL ID bae79e41-1b56-4bcc-9635-ffcf85fa0fdeSPL set ID f5e0ce64-605d-487c-a7b9-c00457925d94RxCUI 308694, 358917
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
N445802050901followed by a unit qualifier and the quantityPackage 45802-0509-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Clindamycin and benzoyl peroxide topical gel, 1%/5% is indicated for the topical treatment of acne vulgaris.
Excerpt only. Read the full label for complete information.
About NDC 45802-509
- What is NDC 45802-509?
- 45802-509 is the product NDC for clindamycin and benzoyl peroxide kit, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- clindamycin and benzoyl peroxide.
- 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 clindamycin and benzoyl peroxide?
- 7 other product NDCs are listed under this name. See all clindamycin and benzoyl peroxide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other clindamycin and benzoyl peroxide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clindamycin and Benzoyl Peroxide | — | Kit | Encube Ethicals, Inc. | 21922-068 | 21922-0068-4321922-0068-4421922-0068-45+1 more |
| clindamycin and benzoyl peroxide | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g | GelTopical | Glenmark Pharmaceuticals Inc., USA | 68462-859 | 68462-0859-2468462-0859-27 |
| clindamycin and benzoyl peroxide | — | Kit | Padagis Israel Pharmaceuticals Ltd | 45802-510 | 45802-0510-03 |
| clindamycin and benzoyl peroxide | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g | GelTopical | NorthStar RxLLC | 16714-984 | 16714-0984-2516714-0984-50 |
| clindamycin and benzoyl peroxide | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g | GelTopical | Glenmark Pharmaceuticals Inc., USA | 68462-486 | 68462-0486-1968462-0486-2468462-0486-27 |
| Clindamycin And Benzoyl Peroxide | — | Kit | Padagis Israel Pharmaceuticals Ltd | 45802-507 | 45802-0507-02 |
| Clindamycin And Benzoyl Peroxide | — | Kit | Bryant Ranch Prepack | 72162-2074 | 72162-2074-02 |
Other NDCs under ANDA 202440
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 And Benzoyl Peroxide | — | Kit | Padagis Israel Pharmaceuticals Ltd | 45802-507 |
| clindamycin and benzoyl peroxide | — | Kit | Padagis Israel Pharmaceuticals Ltd | 45802-510 |
| Clindamycin And Benzoyl Peroxide | — | Kit | Bryant Ranch Prepack | 72162-2074 |