Prescription drug · ANDA
cephalexin NDC 68180-440
Cephalexin 125 mg/5mL · For suspension · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-440-01 | 6818004400168180044001 | 100 mL in 1 BOTTLE (68180-440-01)Marketed from Aug 21, 2017 | |
| 68180-440-02 | 6818004400268180044002 | 200 mL in 1 BOTTLE (68180-440-02)Marketed from Sep 6, 2017 |
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 — 125 mg/5mL
- Dosage form
- For suspension
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.NDC labeler code 68180
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065234
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 68180-440_e632e484-a5f0-46b3-8204-7221083d2528SPL ID e632e484-a5f0-46b3-8204-7221083d2528SPL set ID 25ef498a-7a7e-4543-a544-b9d0e99f9cd9RxCUI 309110, 309113UNII OBN7UDS42Y
- 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
N468180044001followed by a unit qualifier and the quantityPackage 68180-0440-01. 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 .
Indications (excerpt from the label)
Cephalexin USP is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria in adults and pediatric patients aged one year and older: Respiratory tract infection ( 1.1 ) Otitis media ( 1.2 ) Skin and skin structure infections ( 1.3 ) Bone infections ( 1.4 ) Genitourinary tract infections ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs, cephalexin for oral suspension should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.6 ) 1.1 Respiratory Tract Infections Cephalexin …
Excerpt only. Read the full label for complete information.
About NDC 68180-440
- What is NDC 68180-440?
- 68180-440 is the product NDC for cephalexin, Cephalexin 125 mg/5mL for suspension, listed with the FDA by Lupin Pharmaceuticals, Inc.. It has 2 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?
- Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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 065234
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 250 mg/5mL | For suspensionOral | A-S Medication Solutions | 50090-6445 |
| cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | A-S Medication Solutions | 50090-7091 |
| cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-3587 |
| cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | Lupin Pharmaceuticals, Inc. | 68180-441 |
| cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-8686 |
| cephalexin | Cephalexin 250 mg/5mL | For suspensionOral | Proficient Rx LP | 71205-553 |