Prescription drug · ANDA
Clindamycin Palmitate Hydrochloride (Pediatric) NDC 16714-483
Clindamycin palmitate hydrochloride 75 mg/5mL · Solution · Oral · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-483-01 | 1671404830116714048301 | 1 BOTTLE in 1 CARTON (16714-483-01) / 100 mL in 1 BOTTLEMarketed from Apr 30, 2013 | |
| 16714-483-02 | 1671404830216714048302 | 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 LLCNDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202409
- Marketing start
- Listing expires
- 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
N416714048301followed by a unit qualifier and the quantityPackage 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Clindamycin palmitate hydrochloride for oral solution (Pediatric) 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…
Excerpt only. Read the full label for complete information.
About NDC 16714-483
- What is NDC 16714-483?
- 16714-483 is the product NDC for Clindamycin Palmitate Hydrochloride (Pediatric), Clindamycin palmitate hydrochloride 75 mg/5mL solution, listed with the FDA by NorthStar Rx LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clindamycin Palmitate Hydrochloride (Pediatric).
- What is the active ingredient?
- Clindamycin palmitate hydrochloride.
- Who is the labeler?
- NorthStar Rx LLC, NDC labeler code 16714. 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 Palmitate Hydrochloride (Pediatric)?
- 5 other product NDCs are listed under this name. See all Clindamycin Palmitate Hydrochloride (Pediatric) NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clindamycin Palmitate Hydrochloride (Pediatric) products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clindamycin Palmitate Hydrochloride (Pediatric)clindamycin palmitate hydrochloride | Clindamycin palmitate hydrochloride 75 mg/5mL | Powder, For solutionOral | Amneal Pharmaceuticals of New York LLC | 53746-468 | 53746-0468-19 |
| Clindamycin Palmitate Hydrochloride (Pediatric) | Clindamycin palmitate hydrochloride 75 mg/5mL | SolutionOral | Aurobindo Pharma Limited | 65862-596 | 65862-0596-0165862-0596-02 |
| CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric)clindamycin palmitate hydrochloride | Clindamycin palmitate hydrochloride 75 mg/5mL | Granule, For solutionOral | Bryant Ranch Prepack | 63629-2391 | 63629-2391-01 |
| CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric)clindamycin palmitate hydrochloride | Clindamycin palmitate hydrochloride 75 mg/5mL | Granule, For solutionOral | Rising Pharma Holdings, Inc. | 64980-511 | 64980-0511-10 |
| CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric)clindamycin palmitate hydrochloride | Clindamycin palmitate hydrochloride 75 mg/5mL | Granule, For solutionOral | Bryant Ranch Prepack | 72162-1809 | 72162-1809-01 |
Other NDCs under ANDA 202409
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Clindamycin Palmitate Hydrochloride (Pediatric) | Clindamycin palmitate hydrochloride 75 mg/5mL | SolutionOral | Aurobindo Pharma Limited | 65862-596 |