Prescription drug · ANDA
Aprepitant NDC 13668-593
Aprepitant 125 mg/1 · Capsule · Oral · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-593-86 | 1366805938613668059386 | 6 BLISTER PACK in 1 CARTON (13668-593-86) / 1 CAPSULE in 1 BLISTER PACK (13668-593-80)Marketed from Oct 21, 2020 |
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)
- Aprepitant
- Generic name (nonproprietary)
- aprepitant
- Active ingredients
- Aprepitant — 125 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Torrent Pharmaceuticals LimitedNDC labeler code 13668
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211835
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Neurokinin 1 Antagonists (Mechanism)
- Identifiers
- Product ID 13668-593_d61cf041-fb75-4b56-949d-1f2f93acf4d0SPL ID d61cf041-fb75-4b56-949d-1f2f93acf4d0SPL set ID af9b6086-4bf2-472c-8740-4134eaaebaceRxCUI 403810, 403811, 644088, 754508UNII 1NF15YR6UY
- Pharmacologic class
- Substance P/Neurokinin-1 Receptor Antagonist
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
N413668059386followed by a unit qualifier and the quantityPackage 13668-0593-86. 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)
Aprepitant is a substance P/neurokinin 1 (NK1) receptor antagonist. Aprepitant capsules are indicated • in combination with other antiemetic agents, in patients 12 years of age and older for prevention of: o acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin ( 1.1 ) o nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) ( 1.1 ) • for prevention of postoperative nausea and vomiting (PONV) in adults ( 1.2 ) Limitations of Use : ( 1.3 ) • Aprepitant has not been studied for treatment of established nausea and vomiting. • Chronic …
Excerpt only. Read the full label for complete information.
About NDC 13668-593
- What is NDC 13668-593?
- 13668-593 is the product NDC for Aprepitant, Aprepitant 125 mg/1 capsule, listed with the FDA by Torrent Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Aprepitant.
- What is the active ingredient?
- Aprepitant.
- Who is the labeler?
- Torrent Pharmaceuticals Limited, NDC labeler code 13668. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Aprepitant?
- 19 other product NDCs are listed under this name. See all Aprepitant NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Aprepitant products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Aprepitant | Aprepitant 125 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-668 | 68001-0668-19 |
| Aprepitant | — | Kit | BluePoint Laboratories | 68001-669 | 68001-0669-15 |
| Aprepitant | Aprepitant 40 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-666 | 68001-0666-0168001-0666-17 |
| Aprepitant | Aprepitant 80 mg/1 | CapsuleOral | BluePoint Laboratories | 68001-667 | 68001-0667-0168001-0667-19 |
| Aprepitant | Aprepitant 40 mg/1 | CapsuleOral | Torrent Pharmaceuticals Limited | 13668-591 | 13668-0591-8113668-0591-82 |
| Aprepitant | Aprepitant 80 mg/1 | CapsuleOral | Torrent Pharmaceuticals Limited | 13668-592 | 13668-0592-8413668-0592-86 |
| Aprepitant | — | Kit | Torrent Pharmaceuticals Limited | 13668-594 | 13668-0594-87 |
| Aprepitant | Aprepitant 40 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-701 | 51407-0701-0151407-0701-05 |
| Aprepitant | Aprepitant 80 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-702 | 51407-0702-0251407-0702-06 |
| Aprepitant | Aprepitant 125 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-703 | 51407-0703-06 |
Other NDCs under ANDA 211835
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 |
|---|---|---|---|---|
| Aprepitant | Aprepitant 40 mg/1 | CapsuleOral | Torrent Pharmaceuticals Limited | 13668-591 |
| Aprepitant | Aprepitant 80 mg/1 | CapsuleOral | Torrent Pharmaceuticals Limited | 13668-592 |
| Aprepitant | — | Kit | Torrent Pharmaceuticals Limited | 13668-594 |
| Aprepitant | Aprepitant 40 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-701 |
| Aprepitant | Aprepitant 80 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-702 |
| Aprepitant | Aprepitant 125 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-703 |
| Aprepitant | — | Kit | Golden State Medical Supply, Inc. | 51407-704 |