Prescription drug · ANDA
Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% NDC 21922-050
Clindamycin phosphate 10 mg/g; Tretinoin .25 mg/g · Gel · Topical · Encube Ethicals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21922-050-05 | 2192200500521922005005 | 1 TUBE in 1 CARTON (21922-050-05) / 30 g in 1 TUBEMarketed from Sep 4, 2023 | |
| 21922-050-07 | 2192200500721922005007 | 1 TUBE in 1 CARTON (21922-050-07) / 60 g in 1 TUBEMarketed from Sep 4, 2023 |
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 and Tretinoin Gel 1.2%/0.025%
- Generic name (nonproprietary)
- clindamycin phosphate and tretinoin gel 1.2%/0.025%
- Active ingredients
- Clindamycin phosphate — 10 mg/gTretinoin — .25 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Encube Ethicals, Inc.NDC labeler code 21922
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216943
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)Retinoids (Chemical structure)
- Identifiers
- Product ID 21922-050_854a8cf5-cfcf-4189-af34-e111363266a1SPL ID 854a8cf5-cfcf-4189-af34-e111363266a1SPL set ID 1f772408-52a3-45b2-b053-8fc78948983cRxCUI 882548UNII EH6D7113I8, 5688UTC01RUPC 0321922050073, 0321922050059
- Pharmacologic class
- Lincosamide Antibacterial; Retinoid
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
N421922005005followed by a unit qualifier and the quantityPackage 21922-0050-05. 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)
Clindamycin phosphate and tretinoin gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Clindamycin phosphate and tretinoin gel is a lincosamide antibiotic and retinoid combination product indicated for the topical treatment of acne vulgaris in patients 12 years or older. (1)
Excerpt only. Read the full label for complete information.
About NDC 21922-050
- What is NDC 21922-050?
- 21922-050 is the product NDC for Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%, Clindamycin phosphate 10 mg/g; Tretinoin .25 mg/g gel, 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 Phosphate and Tretinoin Gel 1.2%/0.025%.
- What is the active ingredient?
- Clindamycin phosphate, Tretinoin.
- 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 Phosphate and Tretinoin Gel 1.2%/0.025%?
- 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.