NDC codes

FDA NDC Directory
Product NDC (as listed)0009-0331Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00009-0331Add 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
0009-0331-0200009033102100 CAPSULE in 1 BOTTLE (0009-0331-02)Marketed from May 22, 1970

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Cleocin Hydrochloride
Generic name (nonproprietary)
clindamycin hydrochloride
Active ingredients
Clindamycin hydrochloride — 75 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 050162
Marketing start
Listing expires
Other FDA classes
Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers
Product ID 0009-0331_3cdb1eb4-26cd-495d-b9d2-0ad980fadc2bSPL ID 3cdb1eb4-26cd-495d-b9d2-0ad980fadc2b
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400009033102 followed by a unit qualifier and the quantity

Package 00009-0331-02. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under NDA 050162

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

FDA NDC Directory listings under NDA 050162
ProductStrengthForm · routeLabelerProduct NDC
Cleocin Hydrochlorideclindamycin hydrochlorideClindamycin hydrochloride 300 mg/1CapsuleOralPharmacia & Upjohn Company LLC0009-0395
Cleocin Hydrochlorideclindamycin hydrochlorideClindamycin hydrochloride 150 mg/1CapsuleOralPharmacia & Upjohn Company LLC0009-0225

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