Acetazolamide NDC 62135-612

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-612Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0612Add 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
62135-612-60	62135061260	60 CAPSULE, EXTENDED RELEASE in 1 PACKAGE (62135-612-60)Marketed from May 9, 2023

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: Chartwell RX, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040904
Marketing start: Feb 15, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Carbonic Anhydrase Inhibitors (Mechanism)Sulfonamides (Chemical structure)
Identifiers: Product ID 62135-612_2420ae6d-8967-ef58-e063-6394a90a9656SPL ID 2420ae6d-8967-ef58-e063-6394a90a9656SPL set ID e8e48a25-5f6c-4b5a-a5f2-ee87aabea33bRxCUI 562524UNII O3FX965V0IUPC 0362135612603
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

N462135061260 followed by a unit qualifier and the quantity

Package 62135-0612-60. 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 Oct 10, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE: For adjunctive treatment of: chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angleclosure 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 040904

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

FDA NDC Directory listings under ANDA 040904
Product	Strength	Form · route	Labeler	Product NDC
Acetazolamide	Acetazolamide 500 mg/1	Capsule, Extended releaseOral	REMEDYREPACK INC.	70518-4646
Acetazolamide	Acetazolamide 500 mg/1	Capsule, Extended releaseOral	A-S Medication Solutions	50090-5945
Acetazolamide	Acetazolamide 500 mg/1	Capsule, Extended releaseOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-787