What is NDC 65649-003?

65649-003 is the product NDC for Trulance Immediate release (plecanatide), Plecanatide 3 mg/1 tablet, listed with the FDA by Salix Pharmaceuticals Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Trulance Immediate release (Plecanatide).

Salix Pharmaceuticals Inc., NDC labeler code 65649. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Trulance Immediate release?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Trulance Immediate release NDC 65649-003

NDC codes

FDA NDC Directory

Product NDC (as listed)65649-003Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65649-0003Add 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 NDC	11-digit (billing)	Package
65649-003-01	6564900030165649000301	1 BOTTLE in 1 CARTON (65649-003-01) / 1 TABLET in 1 BOTTLEMarketed from Feb 21, 2017
65649-003-03	6564900030365649000303	1 BOTTLE in 1 CARTON (65649-003-03) / 3 TABLET in 1 BOTTLEMarketed from Feb 21, 2017
65649-003-07	6564900030765649000307	1 BOTTLE in 1 CARTON (65649-003-07) / 7 TABLET in 1 BOTTLEMarketed from Feb 21, 2017 · Sample package
65649-003-30	6564900033065649000330	30 TABLET in 1 BOTTLE (65649-003-30)Marketed from Feb 21, 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): Trulance Immediate releaseSuffix: Immediate release
Generic name (nonproprietary): plecanatide
Active ingredients: Plecanatide — 3 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Salix Pharmaceuticals Inc.NDC labeler code 65649
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208745
Marketing start: Feb 21, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Guanylate Cyclase Activators (Mechanism)
Identifiers: Product ID 65649-003_154842e6-a919-ba71-e063-6394a90aebd4SPL ID 154842e6-a919-ba71-e063-6394a90aebd4SPL set ID fe2895bf-71a6-493a-b0ca-e06b2dfefc82RxCUI 1873757, 1873765UNII 7IK8Z952OKUPC 0365649003301
Pharmacologic class: Guanylate Cyclase-C Agonist

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

N465649000301 followed by a unit qualifier and the quantity

Package 65649-0003-01. 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 Apr 4, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

TRULANCE is indicated in adults for the treatment of: chronic idiopathic constipation (CIC). irritable bowel syndrome with constipation (IBS-C). TRULANCE is a guanylate cyclase-C agonist indicated in adults for treatment of: chronic idiopathic constipation (CIC). ( 1 ) irritable bowel syndrome with constipation (IBS-C). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65649-003

What is NDC 65649-003?: 65649-003 is the product NDC for Trulance Immediate release (plecanatide), Plecanatide 3 mg/1 tablet, listed with the FDA by Salix Pharmaceuticals Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Trulance Immediate release (Plecanatide).
What is the active ingredient?: Plecanatide.
Who is the labeler?: Salix Pharmaceuticals Inc., NDC labeler code 65649. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Trulance Immediate release?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Trulance Immediate release (Plecanatide) NDC 65649-003