NDC codes

FDA NDC Directory
Product NDC (as listed)65841-762Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65841-0762Add 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
65841-762-0165841076201100 CAPSULE in 1 BOTTLE (65841-762-01)Marketed from Apr 10, 2019
65841-762-0565841076205500 CAPSULE in 1 BOTTLE (65841-762-05)Marketed from Apr 10, 2019
65841-762-066584107620630 CAPSULE in 1 BOTTLE (65841-762-06)Marketed from Apr 10, 2019
65841-762-10658410762101000 CAPSULE in 1 BOTTLE (65841-762-10)Marketed from Apr 10, 2019
65841-762-166584107621690 CAPSULE in 1 BOTTLE (65841-762-16)Marketed from Apr 10, 2019
65841-762-306584107623010 BLISTER PACK in 1 CARTON (65841-762-30) / 10 CAPSULE in 1 BLISTER PACKMarketed from Apr 10, 2019

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
Route
Oral
Labeler
Zydus Lifesciences LimitedNDC labeler code 65841
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205301
Marketing start
Listing expires
Other FDA classes
Carbonic Anhydrase Inhibitors (Mechanism)Sulfonamides (Chemical structure)
Identifiers
Product ID 65841-762_bb74273d-215a-4983-bfa1-7d649f6872d5SPL ID bb74273d-215a-4983-bfa1-7d649f6872d5SPL set ID 2c1d9078-c15f-4dce-bc26-edfa5400fa9bRxCUI 562524UNII O3FX965V0IUPC 0365841762013
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

N465841076201 followed by a unit qualifier and the quantity

Package 65841-0762-01. 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)

About NDC 65841-762

What is NDC 65841-762?
65841-762 is the product NDC for acetazolamide, Acetazolamide 500 mg/1 capsule, listed with the FDA by Zydus Lifesciences Limited. It has 6 package NDCs, 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?
Zydus Lifesciences Limited, NDC labeler code 65841. 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?
70 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AcetazolamideAcetazolamide 500 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-464670518-4646-00
AcetazolamideAcetazolamide 125 mg/1TabletOralMarlex Pharmaceuticals, Inc.10135-83010135-0830-01
AcetazolamideAcetazolamide 250 mg/1TabletOralMarlex Pharmaceuticals, Inc.10135-83110135-0831-01
Acetazolamideacetazolamide sodiumAcetazolamide sodium 500 mg/5mLInjection, Powder, For solutionIntravenousSagent Pharmaceuticals25021-83925021-0839-20
AcetazolamideAcetazolamide sodium 500 mg/5mLInjection, Powder, Lyophilized, For solutionIntravenousGland Pharma Limited68083-66168083-0661-01
AcetazolamideAcetazolamide 125 mg/1TabletOralAurobindo Pharma Limited59651-90559651-0905-01
AcetazolamideAcetazolamide 250 mg/1TabletOralAurobindo Pharma Limited59651-90659651-0906-01
AcetazolamideAcetazolamide 125 mg/1TabletOralAarkish Pharmaceuticals NJ Inc.81005-10481005-0104-0181005-0104-10
AcetazolamideAcetazolamide 250 mg/1TabletOralAarkish Pharmaceuticals NJ Inc.81005-10581005-0105-0181005-0105-10
AcetazolamideAcetazolamide 125 mg/1TabletOralAjanta Pharma USA Inc.27241-13227241-0132-04

All 71 acetazolamide NDCs

Other NDCs under ANDA 205301

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

FDA NDC Directory listings under ANDA 205301
ProductStrengthForm · routeLabelerProduct NDC
acetazolamideAcetazolamide 500 mg/1CapsuleOralZydus Pharmaceuticals (USA) Inc.70710-1591
acetazolamideAcetazolamide 500 mg/1CapsuleOralAmerican Health Packaging60687-578

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