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 NDC11-digit (billing)PackageCopy
16729-331-0116729033101100 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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207659
Marketing start
Listing expires
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 .

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)

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
ProductStrengthForm · routeLabelerProduct NDC
acetazolamideAcetazolamide 500 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-9729

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in