Prescription drug · ANDA
Cephalexin NDC 63187-046
Cephalexin 500 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-046-06 | 6318700460663187004606 | 6 CAPSULE in 1 BOTTLE (63187-046-06)Marketed from Apr 2, 2018 | |
| 63187-046-14 | 6318700461463187004614 | 14 CAPSULE in 1 BOTTLE (63187-046-14)Marketed from Oct 1, 2018 | |
| 63187-046-15 | 6318700461563187004615 | 15 CAPSULE in 1 BOTTLE (63187-046-15)Marketed from Mar 1, 2019 | |
| 63187-046-20 | 6318700462063187004620 | 20 CAPSULE in 1 BOTTLE (63187-046-20)Marketed from Apr 1, 2014 | |
| 63187-046-21 | 6318700462163187004621 | 21 CAPSULE in 1 BOTTLE (63187-046-21)Marketed from Apr 1, 2014 | |
| 63187-046-28 | 6318700462863187004628 | 28 CAPSULE in 1 BOTTLE (63187-046-28)Marketed from Jan 1, 2018 | |
| 63187-046-30 | 6318700463063187004630 | 30 CAPSULE in 1 BOTTLE (63187-046-30)Marketed from Apr 1, 2014 | |
| 63187-046-40 | 6318700464063187004640 | 40 CAPSULE in 1 BOTTLE (63187-046-40)Marketed from Apr 1, 2014 |
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)
- Cephalexin
- Generic name (nonproprietary)
- cephalexin
- Active ingredients
- Cephalexin — 500 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065229
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 63187-046_8202b9f1-6f03-4f64-a300-062d1679d0e8SPL ID 8202b9f1-6f03-4f64-a300-062d1679d0e8SPL set ID dec3a1ef-1e85-4236-804b-e7a343d3a58fRxCUI 309114UNII OBN7UDS42YUPC 0363187046286
- 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
N463187004606followed by a unit qualifier and the quantityPackage 63187-0046-06. 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 Cephalexin Capsules USP are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes . (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.) Otitis media due to Streptococcus pneumoniae , Ha…
Excerpt only. Read the full label for complete information.
About NDC 63187-046
- What is NDC 63187-046?
- 63187-046 is the product NDC for Cephalexin, Cephalexin 500 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 8 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cephalexin.
- What is the active ingredient?
- Cephalexin.
- 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 Cephalexin?
- 183 other product NDCs are listed under this name. See all Cephalexin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cephalexin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4143 | 68788-4143-0168788-4143-0268788-4143-03+6 more |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-4167 | 68788-4167-0268788-4167-0368788-4167-04+3 more |
| Cephalexin | Cephalexin 125 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 59651-322 | 59651-0322-0159651-0322-02 |
| Cephalexin | Cephalexin 250 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 59651-323 | 59651-0323-0159651-0323-02 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Coupler LLC | 67046-1245 | 67046-1245-03 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | AVKARE | 42291-006 | 42291-0006-50 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | AVKARE | 42291-007 | 42291-0007-50 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Northwind Health Company, LLC | 82868-095 | 82868-0095-1082868-0095-2082868-0095-21+3 more |
| Cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | REMEDYREPACK INC. | 70518-4511 | 70518-4511-00 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Coupler, LLC | 67046-1533 | 67046-1533-03 |
Other NDCs under ANDA 065229
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 |
|---|---|---|---|---|
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Coupler LLC | 67046-1245 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4406 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-4516 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-5241 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-121 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-122 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3448 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3857 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-052 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-287 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-288 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-736 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Asclemed USA, Inc | 76420-831 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | ADVANCED RX PHARMACY OF TENNESSEE, LLC | 80425-0005 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | ADVANCED RX PHARMACY OF TENNESSEE, LLC | 80425-0006 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Sportpharm LLC | 85766-004 |