Prescription drug · ANDA
Clindamycin Phoaphate Topical Solution USP, 1% NDC 21922-002
clindamycin phosphate topical solution usp, 1% · Clindamycin phosphate 10 mg/mL · Solution · Topical · Encube Ethicals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21922-002-01 | 2192200020121922000201 | 1 BOTTLE in 1 CARTON (21922-002-01) / 60 mL in 1 BOTTLEMarketed from Mar 4, 2019 | |
| 21922-002-21 | 2192200022121922000221 | 1 BOTTLE in 1 CARTON (21922-002-21) / 30 mL in 1 BOTTLEMarketed from Jul 13, 2020 |
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 Phoaphate Topical Solution USP, 1%
- Generic name (nonproprietary)
- clindamycin phosphate topical solution usp, 1%
- Active ingredients
- Clindamycin phosphate — 10 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Encube Ethicals, Inc.NDC labeler code 21922
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209914
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
- Identifiers
- Product ID 21922-002_0babc3d6-8dfa-4034-8811-24af75b21048SPL ID 0babc3d6-8dfa-4034-8811-24af75b21048SPL set ID b2dfb76b-db09-43e7-8366-6791449a4918RxCUI 309333UNII EH6D7113I8UPC 0321922002218, 0321922002010
- 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
N421922000201followed by a unit qualifier and the quantityPackage 21922-0002-01. 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 solution USP, 1% 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 21922-002
- What is NDC 21922-002?
- 21922-002 is the product NDC for Clindamycin Phoaphate Topical Solution USP, 1%, Clindamycin phosphate 10 mg/mL solution, listed with the FDA by Encube Ethicals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clindamycin Phoaphate Topical Solution USP, 1% (Clindamycin Phosphate Topical Solution USP, 1%).
- What is the active ingredient?
- Clindamycin phosphate.
- Who is the labeler?
- Encube Ethicals, Inc., NDC labeler code 21922. 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 Phoaphate Topical Solution USP, 1%?
- 1 other product NDC are listed under this name. See all Clindamycin Phoaphate Topical Solution USP, 1% NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clindamycin Phoaphate Topical Solution USP, 1% 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 Phoaphate Topical Solution USP, 1%clindamycin phosphate topical solution usp, 1% | Clindamycin phosphate 10 mg/mL | SolutionTopical | Northstar Rx LLC | 72603-321 | 72603-0321-0172603-0321-02 |
Other NDCs under ANDA 209914
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 Phoaphate Topical Solution USP, 1%clindamycin phosphate topical solution usp, 1% | Clindamycin phosphate 10 mg/mL | SolutionTopical | Northstar Rx LLC | 72603-321 |
| Clindamycin Phoaphate Topical USP, 1%clindamycin phosphate topical usp, 1% | Clindamycin phosphate 10 mg/mL | SolutionTopical | A-S Medication Solutions | 50090-6592 |