NDC codes

FDA NDC Directory
Product NDC (as listed)16729-272Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16729-0272Add 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
16729-272-10167290272101672902721030 TABLET, FILM COATED in 1 BOTTLE (16729-272-10)Marketed from Jan 16, 2019

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)
Prasugrel
Generic name (nonproprietary)
prasugrel
Active ingredients
Prasugrel hydrochloride — 5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Accord Healthcare Inc.NDC labeler code 16729
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205987
Marketing start
Listing expires
Other FDA classes
Decreased Platelet Aggregation (Physiologic effect)P2Y12 Receptor Antagonists (Mechanism)
Identifiers
Product ID 16729-272_0e2f030a-d262-a36c-e063-6294a90a40efSPL ID 0e2f030a-d262-a36c-e063-6294a90a40efSPL set ID cd6bf899-06b7-4f52-96c5-ffc94a7288ffRxCUI 855812, 855818UNII G89JQ59I13
Pharmacologic class
P2Y12 Platelet Inhibitor

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

N416729027210 followed by a unit qualifier and the quantity

Package 16729-0272-10. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Prasugrel is a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows: Patients with unstable angina or, non-ST-elevation myocardial infarction (NSTEMI) ( 1.1 ). Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI ( 1.1 ). 1.1 Acute Coronary Syndrome Prasugrel tablets are indicated to reduce the rate of thrombotic CV events (including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16729-272

What is NDC 16729-272?
16729-272 is the product NDC for Prasugrel, Prasugrel hydrochloride 5 mg/1 tablet, film coated, listed with the FDA by Accord Healthcare Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Prasugrel.
What is the active ingredient?
Prasugrel hydrochloride.
Who is the labeler?
Accord Healthcare Inc., NDC labeler code 16729. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Prasugrel?
18 other product NDCs are listed under this name. See all Prasugrel 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 Prasugrel NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
PrasugrelPrasugrel hydrochloride 10 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-88360687-0883-21
PrasugrelPrasugrel hydrochloride 10 mg/1Tablet, Film coatedOralApotex Corp.60505-485660505-4856-03
PrasugrelPrasugrel hydrochloride 5 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-30129300-0301-13
PrasugrelPrasugrel hydrochloride 10 mg/1Tablet, Film coatedOralUnichem Pharmaceuticals (USA), Inc.29300-30229300-0302-13
PrasugrelPrasugrel hydrochloride 10 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-27316729-0273-10
PrasugrelPrasugrel hydrochloride 5 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals LLC65162-00165162-0001-03
PrasugrelPrasugrel hydrochloride 10 mg/1Tablet, Film coatedOralAmneal Pharmaceuticals LLC65162-00265162-0002-03
PrasugrelPrasugrel hydrochloride 5 mg/1Tablet, Film coatedOralPanacea Biotec Limited43817-23943817-0239-01
PrasugrelPrasugrel hydrochloride 10 mg/1Tablet, Film coatedOralPanacea Biotec Limited43817-24043817-0240-01
PrasugrelPrasugrel hydrochloride 5 mg/1Tablet, Film coatedOralApotex Corp.60505-464260505-4642-03

All 19 Prasugrel NDCs

Other NDCs under ANDA 205987

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

FDA NDC Directory listings under ANDA 205987
ProductStrengthForm · routeLabelerProduct NDC
PrasugrelPrasugrel hydrochloride 10 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-273

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