What is NDC 16729-331?

16729-331 is the product NDC for acetazolamide, Acetazolamide 500 mg/1 capsule, extended 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 acetazolamide?

71 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

acetazolamide NDC 16729-331 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-331Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0331Add 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
16729-331-01	16729033101	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16729-331-01)Marketed from Nov 19, 2021

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): acetazolamide
Generic name (nonproprietary): acetazolamide
Active ingredients: Acetazolamide — 500 mg/1
Dosage form: Capsule, Extended 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 207659
Marketing start: Nov 19, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Carbonic Anhydrase Inhibitors (Mechanism)Sulfonamides (Chemical structure)
Identifiers: Product ID 16729-331_45ffaa19-26c0-d41f-e063-6394a90ad7c3SPL ID 45ffaa19-26c0-d41f-e063-6394a90ad7c3SPL set ID 9a368b35-cd51-47ad-83cc-ccc56c4585e8RxCUI 562524UNII O3FX965V0I
Pharmacologic class: Carbonic Anhydrase 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

N416729033101 followed by a unit qualifier and the quantity

Package 16729-0331-01. 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 Dec 15, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE: For adjunctive treatment of: chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide extended-release capsules are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness despite gradual ascent.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16729-331

What is NDC 16729-331?: 16729-331 is the product NDC for acetazolamide, Acetazolamide 500 mg/1 capsule, extended 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?: acetazolamide.
What is the active ingredient?: Acetazolamide.
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 acetazolamide?: 71 other product NDCs are listed under this name. See all acetazolamide 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 acetazolamide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Acetazolamideacetazolamide sodium	Acetazolamide sodium 500 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Mylan Institutional LLC	72078-092	72078-0092-50
Acetazolamide	Acetazolamide 500 mg/1	Capsule, Extended releaseOral	REMEDYREPACK INC.	70518-4646	70518-4646-00
Acetazolamide	Acetazolamide 125 mg/1	TabletOral	Marlex Pharmaceuticals, Inc.	10135-830	10135-0830-01
Acetazolamide	Acetazolamide 250 mg/1	TabletOral	Marlex Pharmaceuticals, Inc.	10135-831	10135-0831-01
Acetazolamideacetazolamide sodium	Acetazolamide sodium 500 mg/5mL	Injection, Powder, For solutionIntravenous	Sagent Pharmaceuticals	25021-839	25021-0839-20
Acetazolamide	Acetazolamide sodium 500 mg/5mL	Injection, Powder, Lyophilized, For solutionIntravenous	Gland Pharma Limited	68083-661	68083-0661-01
Acetazolamide	Acetazolamide 125 mg/1	TabletOral	Aurobindo Pharma Limited	59651-905	59651-0905-01
Acetazolamide	Acetazolamide 250 mg/1	TabletOral	Aurobindo Pharma Limited	59651-906	59651-0906-01
Acetazolamide	Acetazolamide 125 mg/1	TabletOral	Aarkish Pharmaceuticals NJ Inc.	81005-104	81005-0104-0181005-0104-10
Acetazolamide	Acetazolamide 250 mg/1	TabletOral	Aarkish Pharmaceuticals NJ Inc.	81005-105	81005-0105-0181005-0105-10

All 72 acetazolamide NDCs

Other NDCs under ANDA 207659

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

FDA NDC Directory listings under ANDA 207659
Product	Strength	Form · route	Labeler	Product NDC
acetazolamide	Acetazolamide 500 mg/1	Capsule, Extended releaseOral	Bryant Ranch Prepack	71335-9729