NDC codes

FDA NDC Directory
Product NDC (as listed)61314-547Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61314-0547Add 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
61314-547-01613140547011 BOTTLE in 1 CARTON (61314-547-01) / 2.5 mL in 1 BOTTLEMarketed from Jan 7, 2011
61314-547-03613140547033 BOTTLE in 1 CARTON (61314-547-03) / 2.5 mL in 1 BOTTLEMarketed from Jan 7, 2011

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)
Latanoprost
Generic name (nonproprietary)
latanoprost
Active ingredients
Latanoprost — 50 ug/mL
Dosage form
Solution
Route
Ophthalmic
Labeler
Sandoz Inc
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091449
Marketing start
Listing expires
Identifiers
Product ID 61314-547_a4388e84-6b82-4d7d-915b-6997d4b44b36SPL ID a4388e84-6b82-4d7d-915b-6997d4b44b36SPL set ID 1fba56a6-c8dc-4f34-b05d-efdea75d2feaRxCUI 314072UNII 6Z5B6HVF6O

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

N461314054701 followed by a unit qualifier and the quantity

Package 61314-0547-01. 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)

Latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Latanoprost ophthalmic solution is a prostaglandin F 2α analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091449

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

FDA NDC Directory listings under ANDA 091449
ProductStrengthForm · routeLabelerProduct NDC
LatanoprostLatanoprost 50 ug/mLSolutionOphthalmicA-S Medication Solutions50090-7062
LatanoprostLatanoprost 50 ug/mLSolutionOphthalmicNuCare Pharmaceuticals, Inc.68071-3884

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