NDC codes

FDA NDC Directory
Product NDC (as listed)21922-050Labeler and product segments. Claims need a package NDC.
Product NDC at billing width21922-0050Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
21922-050-0521922005005219220050051 TUBE in 1 CARTON (21922-050-05) / 30 g in 1 TUBEMarketed from Sep 4, 2023
21922-050-0721922005007219220050071 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

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

N421922005005 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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