What is NDC 16729-189?

16729-189 is the product NDC for Mycophenolic Acid, Mycophenolate sodium 360 mg/1 tablet, delayed release, listed with the FDA by Accord Healthcare Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

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 Mycophenolic Acid?

34 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Mycophenolic Acid NDC 16729-189 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-189Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0189Add 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	Copy
16729-189-29	1672901892916729018929	120 TABLET, DELAYED RELEASE in 1 BOTTLE (16729-189-29)Marketed from Sep 11, 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): Mycophenolic Acid
Generic name (nonproprietary): mycophenolic acid
Active ingredients: Mycophenolate sodium — 360 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: Accord Healthcare Inc.NDC labeler code 16729
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202555
Marketing start: Sep 11, 2017
Listing expires: Dec 31, 2027
Identifiers: Product ID 16729-189_5c533c1f-cdfa-790b-e063-6394a90abc75SPL ID 5c533c1f-cdfa-790b-e063-6394a90abc75
Pharmacologic class: Antimetabolite Immunosuppressant

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

N416729018929 followed by a unit qualifier and the quantity

Package 16729-0189-29. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 16729-189

What is NDC 16729-189?: 16729-189 is the product NDC for Mycophenolic Acid, Mycophenolate sodium 360 mg/1 tablet, delayed release, 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?: Mycophenolic Acid.
What is the active ingredient?: Mycophenolate sodium.
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 Mycophenolic Acid?: 34 other product NDCs are listed under this name. See all Mycophenolic Acid 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 Mycophenolic Acid NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
mycophenolic acid	Mycophenolate sodium 180 mg/1	Tablet, Delayed releaseOral	Stellon Biotech Inc.	85972-161	85972-0161-12
mycophenolic acid	Mycophenolate sodium 360 mg/1	Tablet, Delayed releaseOral	Stellon Biotech Inc.	85972-162	85972-0162-12
Mycophenolic Acid	Mycophenolate sodium 180 mg/1	Tablet, Delayed releaseOral	Ascend Laboratories, LLC	67877-928	67877-0928-0567877-0928-1267877-0928-38
Mycophenolic Acid	Mycophenolate sodium 360 mg/1	Tablet, Delayed releaseOral	Ascend Laboratories, LLC	67877-929	67877-0929-0567877-0929-1267877-0929-38
Mycophenolic Acid	Mycophenolate sodium 360 mg/1	Tablet, Delayed releaseOral	REMEDYREPACK INC.	70518-4391	70518-4391-00
Mycophenolic Acid	Mycophenolate sodium 360 mg/1	Tablet, Delayed releaseOral	Major Pharmaceuticals	0904-7372	00904-7372-0400904-7372-61
Mycophenolic Acid	Mycophenolate sodium 180 mg/1	Tablet, Delayed releaseOral	Biocon Pharma Inc.	70377-126	70377-0126-11
Mycophenolic Acid	Mycophenolate sodium 360 mg/1	Tablet, Delayed releaseOral	Biocon Pharma Inc.	70377-127	70377-0127-11
Mycophenolic Acid	Mycophenolate sodium 180 mg/1	Tablet, Delayed releaseOral	Novugen Pharma (USA) LLC.	82293-012	82293-0012-10
Mycophenolic Acid	Mycophenolate sodium 360 mg/1	Tablet, Delayed releaseOral	Novugen Pharma (USA) LLC.	82293-013	82293-0013-10

All 35 Mycophenolic Acid NDCs

Other NDCs under ANDA 202555

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

FDA NDC Directory listings under ANDA 202555
Product	Strength	Form · route	Labeler	Product NDC
Mycophenolic Acid	Mycophenolate sodium 180 mg/1	Tablet, Delayed releaseOral	Accord Healthcare Inc.	16729-261