NDC codes

FDA NDC Directory
Product NDC (as listed)50090-7313Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-7313Add 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
50090-7313-0500907313001 BOTTLE, DROPPER in 1 CARTON (50090-7313-0) / 5 mL in 1 BOTTLE, DROPPERMarketed from Oct 14, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Generic name (nonproprietary)
atropine sulfate
Active ingredients
Atropine sulfate — 10 mg/mL
Dosage form
Solution/ drops
Route
Ophthalmic
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214752
Marketing start
Listing expires
Other FDA classes
Cholinergic Antagonists (Mechanism)Cholinergic Muscarinic Antagonists (Mechanism)
Identifiers
Product ID 50090-7313_db93edb4-792e-4925-9002-90978afa8cb1SPL ID db93edb4-792e-4925-9002-90978afa8cb1SPL set ID b4736dbc-b7c8-4b33-b7a8-a47c5654a127RxCUI 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

N450090731300 followed by a unit qualifier and the quantity

Package 50090-7313-00. 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, 1% is indicated in adults and pediatric patients aged three (3) months and older for: Atropine is an anticholinergic indicated in adults and pediatric patients aged three (3) months and older for: Cycloplegia ( 1.1 ) Mydriasis ( 1.2 ) Penalization of the healthy eye in the treatment of amblyopia. ( 1.3 ) 1.1 Cycloplegia 1.2 Mydriasis 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 ANDA 214752

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

FDA NDC Directory listings under ANDA 214752
ProductStrengthForm · routeLabelerProduct NDC
Atropineatropine sulfateAtropine sulfate 10 mg/mLSolution/ dropsOphthalmicAmneal Pharmaceuticals NY LLC60219-1748
Atropineatropine sulfateAtropine sulfate 10 mg/mLSolution/ dropsOphthalmicAmneal Pharmaceuticals NY LLC60219-1749
Atropineatropine sulfateAtropine sulfate 10 mg/mLSolution/ dropsOphthalmicAmneal Pharmaceuticals NY LLC60219-1750

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