Clindamycin Hydrochloride NDC 62135-766

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-766Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0766Add 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 NDC	11-digit (billing)	Package	Copy
62135-766-01	62135076601	100 CAPSULE in 1 BOTTLE (62135-766-01)Marketed from Jan 12, 2024

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 Hydrochloride
Generic name (nonproprietary): clindamycin hydrochloride
Active ingredients: Clindamycin hydrochloride — 300 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Chartwell RX, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065243
Marketing start: Aug 12, 2005
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers: Product ID 62135-766_0f266520-6156-ae80-e063-6394a90a8dc6SPL ID 0f266520-6156-ae80-e063-6394a90a8dc6SPL set ID e8167412-882e-4143-93c6-49e68adbcf16RxCUI 197518, 284215, 309329UNII T20OQ1YN1WUPC 0362135766016, 0362135764012, 0362135765019
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

N462135076601 followed by a unit qualifier and the quantity

Package 62135-0766-01. 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 Jan 17, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of colitis, as described in the BOXED WARNING , before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065243

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

FDA NDC Directory listings under ANDA 065243
Product	Strength	Form · route	Labeler	Product NDC
Clindamycin Hydrochloride	Clindamycin hydrochloride 150 mg/1	CapsuleOral	Chartwell RX, LLC	62135-765
Clindamycin Hydrochloride	Clindamycin hydrochloride 75 mg/1	CapsuleOral	Chartwell RX, LLC	62135-764