Prescription drug · ANDA
Cefdinir NDC 63187-616
Cefdinir monohydrate 250 mg/5mL · Powder, For suspension · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-616-00 | 63187061600 | 100 mL in 1 BOTTLE (63187-616-00)Marketed from May 8, 2007 | |
| 63187-616-60 | 63187061660 | 60 mL in 1 BOTTLE (63187-616-60)Marketed from May 8, 2007 |
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)
- Cefdinir
- Generic name (nonproprietary)
- cefdinir
- Active ingredients
- Cefdinir monohydrate — 250 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065332
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 63187-616_aec22cad-186d-4dac-9fe3-c3b4d6075b2cSPL ID aec22cad-186d-4dac-9fe3-c3b4d6075b2cSPL set ID f22acd90-5dc4-406d-af78-5f9c3a674647RxCUI 476576UNII 6E7SN358SEUPC 0363187616007
- Pharmacologic class
- Cephalosporin 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
N463187061600followed by a unit qualifier and the quantityPackage 63187-0616-00. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir for oral suspension USP and other antibacterial drugs, cefdinir for oral suspension USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefdinir for oral suspension USP is indicated for the treatment of patients with mild to moderate infecti…
Excerpt only. Read the full label for complete information.
About NDC 63187-616
- What is NDC 63187-616?
- 63187-616 is the product NDC for Cefdinir, Cefdinir monohydrate 250 mg/5mL powder, for suspension, listed with the FDA by Proficient Rx LP. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cefdinir.
- What is the active ingredient?
- Cefdinir monohydrate.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cefdinir?
- 77 other product NDCs are listed under this name. See all Cefdinir NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cefdinir products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cefdinir | Cefdinir 250 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-4106 | 68788-4106-01 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7563 | 00904-7563-04 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4169 | 70518-4169-0070518-4169-0170518-4169-02+1 more |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-059 | 82868-0059-20 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | AvKARE | 42291-043 | 42291-0043-60 |
| Cefdinir | Cefdinir monohydrate 250 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-8655 | 68788-8655-01 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | American Health Packaging | 60687-699 | 60687-0699-21 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8404 | 68788-8404-02 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Direct_Rx | 72189-423 | 72189-0423-1472189-0423-20 |
| Cefdinir | Cefdinir 300 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-8323 | 68788-8323-02 |
Other NDCs under ANDA 065332
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 |
|---|---|---|---|---|
| Cefdinir | Cefdinir 125 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-4258 |
| Cefdinir | Cefdinir monohydrate 125 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals, Inc. | 68071-3156 |
| Cefdinir | Cefdinir monohydrate 250 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-8655 |
| Cefdinir | Cefdinir monohydrate 250 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-3725 |
| Cefdinir | Cefdinir monohydrate 125 mg/5mL | Powder, For suspensionOral | Teva Pharmaceuticals USA, Inc. | 0093-4136 |
| Cefdinir | Cefdinir monohydrate 250 mg/5mL | Powder, For suspensionOral | Teva Pharmaceuticals USA, Inc. | 0093-4137 |