Prescription drug · ANDA
Cefixime NDC 59651-647
Cefixime 400 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-647-10 | 59651064710 | 1 BLISTER PACK in 1 CARTON (59651-647-10) / 10 CAPSULE in 1 BLISTER PACKMarketed from Mar 23, 2026 | |
| 59651-647-50 | 59651064750 | 50 CAPSULE in 1 BOTTLE (59651-647-50)Marketed from Mar 23, 2026 |
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)
- Cefixime
- Generic name (nonproprietary)
- cefixime
- Active ingredients
- Cefixime — 400 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217607
- Marketing start
- Listing expires
- Other FDA classes
- Cephalosporins (Chemical structure)
- Identifiers
- Product ID 59651-647_9cdb156f-7a99-413e-b49a-ffafaf9e93feSPL ID 9cdb156f-7a99-413e-b49a-ffafaf9e93feSPL set ID 9cdb156f-7a99-413e-b49a-ffafaf9e93feRxCUI 409823UNII 97I1C92E55
- 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
N459651064710followed by a unit qualifier and the quantityPackage 59651-0647-10. 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)
Cefixime is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months and older with the following infections: Uncomplicated Urinary Tract Infections ( 1.1 ) Pharyngitis and Tonsillitis ( 1.3 ) Acute Exacerbations of Chronic Bronchitis ( 1.4 ) Uncomplicated Gonorrhea (cervical/urethral) ( 1.5 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefixime capsules and other antibacterial drugs, cefixime capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.6 ) 1.1 Uncomplicated Urinary Tract Inf…
Excerpt only. Read the full label for complete information.
About NDC 59651-647
- What is NDC 59651-647?
- 59651-647 is the product NDC for Cefixime, Cefixime 400 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cefixime.
- What is the active ingredient?
- Cefixime.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cefixime?
- 10 other product NDCs are listed under this name. See all Cefixime NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cefixime products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cefixime | Cefixime 400 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4759 | 70518-4759-00 |
| Cefixime | Cefixime 400 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-430 | 64980-0430-01 |
| Cefixime | Cefixime 400 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3221 | 70518-3221-0270518-3221-04 |
| Cefixime | Cefixime 400 mg/1 | CapsuleOral | Lupin Pharmaceuticals, Inc. | 68180-423 | 68180-0423-0868180-0423-11 |
| Cefixime | Cefixime 400 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2749 | 70518-2749-0270518-2749-05 |
| Cefixime | Cefixime 400 mg/1 | CapsuleOral | Ascend Laboratories, LLC | 67877-584 | 67877-0584-0167877-0584-0567877-0584-33+1 more |
| Cefixime | Cefixime 100 mg/5mL | Powder, For suspensionOral | Lupin Pharmaceuticals, Inc. | 68180-405 | 68180-0405-01 |
| Cefixime | Cefixime 200 mg/5mL | Powder, For suspensionOral | Lupin Pharmaceuticals, Inc. | 68180-407 | 68180-0407-0368180-0407-04 |
| Cefixime | Cefixime 100 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-751 | 65862-0751-0165862-0751-50 |
| Cefixime | Cefixime 200 mg/5mL | Powder, For suspensionOral | Aurobindo Pharma Limited | 65862-752 | 65862-0752-5065862-0752-75 |
Other NDCs under ANDA 217607
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 |
|---|---|---|---|---|
| Cefixime | Cefixime 400 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4759 |