NDC codes

FDA NDC Directory
Product NDC (as listed)13668-462Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13668-0462Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
13668-462-0113668046201100 CAPSULE in 1 BOTTLE (13668-462-01)Marketed from Jun 30, 2017
13668-462-301366804623030 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

N413668046201 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other anagrelide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AnagrelideAnagrelide hydrochloride .5 mg/1CapsuleOralANI Pharmaceuticals, Inc.70954-87970954-0879-10
AnagrelideAnagrelide hydrochloride 1 mg/1CapsuleOralANI Pharmaceuticals, Inc.70954-88170954-0881-10
anagrelideAnagrelide hydrochloride anhydrous .5 mg/1CapsuleOralTorrent Pharmaceuticals Limited13668-45313668-0453-0113668-0453-30
AnagrelideAnagrelide hydrochloride anhydrous .5 mg/1CapsuleOralChartwell RX, LLC62135-31262135-0312-12
AnagrelideAnagrelide hydrochloride anhydrous 1 mg/1CapsuleOralChartwell RX, LLC62135-31362135-0313-60

Other NDCs under ANDA 209151

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 209151
ProductStrengthForm · routeLabelerProduct NDC
anagrelideAnagrelide hydrochloride anhydrous .5 mg/1CapsuleOralTorrent Pharmaceuticals Limited13668-453

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