Prescription drug · ANDA
Cephalexin NDC 43063-536
Cephalexin 500 mg/1 · Capsule · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-536-04 | 43063053604 | 4 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-04)Marketed from Feb 6, 2014 | |
| 43063-536-06 | 43063053606 | 6 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-06)Marketed from Feb 6, 2014 | |
| 43063-536-08 | 43063053608 | 8 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-08)Marketed from Feb 6, 2014 | |
| 43063-536-09 | 43063053609 | 9 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-09)Marketed from Feb 6, 2014 | |
| 43063-536-10 | 43063053610 | 10 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-10)Marketed from Feb 6, 2014 | |
| 43063-536-14 | 43063053614 | 14 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-14)Marketed from Feb 6, 2014 | |
| 43063-536-20 | 43063053620 | 20 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-20)Marketed from Feb 6, 2014 | |
| 43063-536-21 | 43063053621 | 21 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-21)Marketed from Feb 6, 2014 | |
| 43063-536-28 | 43063053628 | 28 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-28)Marketed from Feb 6, 2014 | |
| 43063-536-30 | 43063053630 | 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-30)Marketed from Feb 6, 2014 | |
| 43063-536-40 | 43063053640 | 40 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-40)Marketed from Feb 6, 2014 | |
| 43063-536-56 | 43063053656 | 56 CAPSULE in 1 BOTTLE, PLASTIC (43063-536-56)Marketed from Feb 6, 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
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090836
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 43063-536_5877f6e0-b52a-47dc-e063-6294a90aad34SPL ID 5877f6e0-b52a-47dc-e063-6294a90aad34SPL set ID a24a3c7c-c0f8-4107-ab30-751bea743d2dRxCUI 309114UNII OBN7UDS42YUPC 0343063536308
- 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
N443063053604followed by a unit qualifier and the quantityPackage 43063-0536-04. 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 is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: 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 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 is indicated for the treatment of respiratory tract infections caused by susceptible …
Excerpt only. Read the full label for complete information.
About NDC 43063-536
- What is NDC 43063-536?
- 43063-536 is the product NDC for Cephalexin, Cephalexin 500 mg/1 capsule, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 12 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?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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+2 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 090836
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/1 | CapsuleOral | Major Pharmaceuticals | 0904-7336 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7337 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | QPharma Inc | 42708-070 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | QPharma Inc | 42708-145 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-497 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-634 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-678 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-3199 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-3202 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-3252 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-3291 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-3427 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5948 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7026 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7027 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7223 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | AvPAK | 50268-151 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | AvPAK | 50268-152 |
| Cephalexin | Cephalexin 250 mg/1 | CapsuleOral | American Health Packaging | 60687-152 |
| Cephalexin | Cephalexin 500 mg/1 | CapsuleOral | American Health Packaging | 60687-163 |
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