Prescription drug · ANDA
clindamycin and benzoyl peroxide NDC 68462-486
Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g · Gel · Topical · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-486-19 | 6846204861968462048619 | 1 JAR in 1 CARTON (68462-486-19) / 25 g in 1 JARMarketed from Mar 14, 2019 | |
| 68462-486-24 | 6846204862468462048624 | 1 JAR in 1 CARTON (68462-486-24) / 35 g in 1 JARMarketed from May 7, 2019 | |
| 68462-486-27 | 6846204862768462048627 | 1 JAR in 1 CARTON (68462-486-27) / 50 g in 1 JARMarketed from Mar 14, 2019 |
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
- Active ingredients
- Clindamycin phosphate — 10 mg/gBenzoyl peroxide — 50 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209252
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 68462-486_03e34592-8f1e-49cd-8a20-824d2b18b4b5SPL ID 03e34592-8f1e-49cd-8a20-824d2b18b4b5SPL set ID 76795d1b-e1f2-4d1d-b42a-f1d4448c63c0RxCUI 358917UNII W9WZN9A0GM, EH6D7113I8UPC 0368462859247, 0368462857861, 0368462484692, 0368462484869, 0368462484982
- 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
N468462048619followed by a unit qualifier and the quantityPackage 68462-0486-19. 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 Gel is indicated for the topical treatment of acne vulgaris.
Excerpt only. Read the full label for complete information.
About NDC 68462-486
- What is NDC 68462-486?
- 68462-486 is the product NDC for clindamycin and benzoyl peroxide, Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g gel, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- clindamycin and benzoyl peroxide.
- What is the active ingredient?
- Clindamycin phosphate, Benzoyl peroxide.
- Who is the labeler?
- Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 | — | Kit | Padagis Israel Pharmaceuticals Ltd | 45802-509 | 45802-0509-01 |
| 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 | — | 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 209252
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 | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g | GelTopical | NorthStar RxLLC | 16714-984 |
| clindamycin and benzoyl peroxide | Clindamycin phosphate 10 mg/g; Benzoyl peroxide 50 mg/g | GelTopical | Glenmark Pharmaceuticals Inc., USA | 68462-859 |