Prescription drug · ANDA
anagrelide NDC 13668-462
Anagrelide hydrochloride anhydrous 1 mg/1 · Capsule · Oral · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-462-01 | 13668046201 | 100 CAPSULE in 1 BOTTLE (13668-462-01)Marketed from Jun 30, 2017 | |
| 13668-462-30 | 13668046230 | 30 CAPSULE in 1 BOTTLE (13668-462-30)Marketed from Jun 30, 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)
- anagrelide
- Generic name (nonproprietary)
- anagrelide
- Active ingredients
- Anagrelide hydrochloride anhydrous — 1 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 209151
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Platelet Production (Physiologic effect)Phosphodiesterase 3 Inhibitors (Mechanism)
- Identifiers
- Product ID 13668-462_7bd56f87-11eb-48d1-a0e4-d5e36c677fdbSPL ID 7bd56f87-11eb-48d1-a0e4-d5e36c677fdbSPL set ID 875cc32a-219c-4b6b-802a-98a47cbc9a78RxCUI 597850, 597852UNII VNS4435G39
- Pharmacologic class
- Platelet-reducing Agent
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
N413668046201followed by a unit qualifier and the quantityPackage 13668-0462-01. 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)
Anagrelide is a platelet reducing agent indicated for the treatment of thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. ( 1 ) Anagrelide capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events .
Excerpt only. Read the full label for complete information.
About NDC 13668-462
- What is NDC 13668-462?
- 13668-462 is the product NDC for anagrelide, Anagrelide hydrochloride anhydrous 1 mg/1 capsule, listed with the FDA by Torrent Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- anagrelide.
- What is the active ingredient?
- Anagrelide hydrochloride anhydrous.
- 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 anagrelide?
- 5 other product NDCs are listed under this name. See all anagrelide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other anagrelide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Anagrelide | Anagrelide hydrochloride .5 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 70954-879 | 70954-0879-10 |
| Anagrelide | Anagrelide hydrochloride 1 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 70954-881 | 70954-0881-10 |
| anagrelide | Anagrelide hydrochloride anhydrous .5 mg/1 | CapsuleOral | Torrent Pharmaceuticals Limited | 13668-453 | 13668-0453-0113668-0453-30 |
| Anagrelide | Anagrelide hydrochloride anhydrous .5 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-312 | 62135-0312-12 |
| Anagrelide | Anagrelide hydrochloride anhydrous 1 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-313 | 62135-0313-60 |
Other NDCs under ANDA 209151
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 |
|---|---|---|---|---|
| anagrelide | Anagrelide hydrochloride anhydrous .5 mg/1 | CapsuleOral | Torrent Pharmaceuticals Limited | 13668-453 |