NDC codes

FDA NDC Directory
Product NDC (as listed)21922-002Labeler and product segments. Claims need a package NDC.
Product NDC at billing width21922-0002Add 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
21922-002-01219220002011 BOTTLE in 1 CARTON (21922-002-01) / 60 mL in 1 BOTTLEMarketed from Mar 4, 2019
21922-002-21219220002211 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
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

N421922000201 followed by a unit qualifier and the quantity

Package 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 209914

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 209914
ProductStrengthForm · routeLabelerProduct NDC
Clindamycin Phoaphate Topical Solution USP, 1%clindamycin phosphate topical solution usp, 1%Clindamycin phosphate 10 mg/mLSolutionTopicalNorthstar Rx LLC72603-321
Clindamycin Phoaphate Topical USP, 1%clindamycin phosphate topical usp, 1%Clindamycin phosphate 10 mg/mLSolutionTopicalA-S Medication Solutions50090-6592

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