NDC codes

FDA NDC Directory
Product NDC (as listed)82260-001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82260-0001Add 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
82260-001-018226000010110 VIAL in 1 CARTON (82260-001-01) / .4 mL in 1 VIALMarketed from Apr 21, 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)
Atropine Sulfate
Generic name (nonproprietary)
atropine sulfate
Active ingredients
Atropine sulfate — 10 mg/mL
Dosage form
Solution
Route
Ophthalmic
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 213581
Marketing start
Listing expires
Other FDA classes
Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers
Product ID 82260-001_4a46793e-5e69-1a65-e063-6294a90a6880SPL ID 4a46793e-5e69-1a65-e063-6294a90a6880SPL set ID e294ce2b-6bb5-4f84-8a6d-ce2402ed926dRxCUI 1190655UNII 03J5ZE7KA5
Pharmacologic class
Anticholinergic; Cholinergic Muscarinic Antagonist

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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N482260000101 followed by a unit qualifier and the quantity

Package 82260-0001-01. 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)

Atropine Sulfate Ophthalmic Solution, USP 1% is indicated for: Atropine is an anti-muscarinic agent indicated for: Mydriasis ( 1.1 ) Cycloplegia ( 1.2 ) Penalization of the healthy eye in the treatment of amblyopia ( 1.3 ) 1.1 Mydriasis 1.2 Cycloplegia 1.3 Penalization of the Healthy Eye in the Treatment of Amblyopia

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 213581

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

FDA NDC Directory listings under NDA 213581
ProductStrengthForm · routeLabelerProduct NDC
Atropine SulfateAtropine sulfate 10 mg/mLSolutionOphthalmicBausch & Lomb Incorporated24208-965

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