Prescription drug · ANDA
Clindamycin Phosphate NDC 45802-128
Clindamycin phosphate 10 mg/mL · Lotion · Topical · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-128-01 | 4580201280145802012801 | 60 mL in 1 BOTTLE (45802-128-01)Marketed from Mar 31, 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 Phosphate
- Generic name (nonproprietary)
- clindamycin phosphate
- Active ingredients
- Clindamycin phosphate — 10 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214604
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 45802-128_073ff89e-39d5-4061-9af6-7fa356b2fce5SPL ID 073ff89e-39d5-4061-9af6-7fa356b2fce5SPL set ID a10dda0c-28fa-4678-8cea-a6ce2fce4b52RxCUI 197519UNII 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
N445802012801followed by a unit qualifier and the quantityPackage 45802-0128-01. 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 phosphate topical lotion is 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.
About NDC 45802-128
- What is NDC 45802-128?
- 45802-128 is the product NDC for Clindamycin Phosphate, Clindamycin phosphate 10 mg/mL lotion, 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 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 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.
Related NDCs: other Clindamycin Phosphate 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 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 |
Other NDCs under ANDA 214604
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 Phosphate | Clindamycin phosphate 10 mg/mL | LotionTopical | Bryant Ranch Prepack | 63629-8632 |
| Clindamycin Phosphate | Clindamycin phosphate 10 mg/mL | LotionTopical | Bryant Ranch Prepack | 63629-9459 |
| Clindamycin Phosphate | Clindamycin phosphate 10 mg/mL | LotionTopical | Bryant Ranch Prepack | 71335-2953 |
| Clindamycin Phosphate | Clindamycin phosphate 10 mg/mL | LotionTopical | Bryant Ranch Prepack | 72162-1395 |