NDC 16714-483

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-483Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0483Add 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
16714-483-01	16714048301	1 BOTTLE in 1 CARTON (16714-483-01) / 100 mL in 1 BOTTLEMarketed from Apr 30, 2013
16714-483-02	16714048302	1 BOTTLE, PLASTIC in 1 CARTON (16714-483-02) / 100 mL in 1 BOTTLE, PLASTICMarketed from Nov 14, 2022

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 Palmitate Hydrochloride (Pediatric)
Generic name (nonproprietary): clindamycin palmitate hydrochloride (pediatric)
Active ingredients: Clindamycin palmitate hydrochloride — 75 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: NorthStar Rx LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202409
Marketing start: Apr 30, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Sebaceous Gland Activity (Physiologic effect)Lincosamides (Chemical structure)Neuromuscular Blockade (Physiologic effect)
Identifiers: Product ID 16714-483_366c8a71-1c5c-47e8-989d-d04503c65f4bSPL ID 366c8a71-1c5c-47e8-989d-d04503c65f4bSPL set ID b35e3714-44d1-4e6a-a124-555ad259fec1RxCUI 562266UNII VN9A8JM7M7
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

N416714048301 followed by a unit qualifier and the quantity

Package 16714-0483-01. 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 202409

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

FDA NDC Directory listings under ANDA 202409
Product	Strength	Form · route	Labeler	Product NDC
Clindamycin Palmitate Hydrochloride (Pediatric)	Clindamycin palmitate hydrochloride 75 mg/5mL	SolutionOral	Aurobindo Pharma Limited	65862-596

Clindamycin Palmitate Hydrochloride (Pediatric) NDC 16714-483