NDC codes

FDA NDC Directory
Product NDC (as listed)68083-609Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68083-0609Add 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
68083-609-0168083060901680830609011 BOTTLE in 1 CARTON (68083-609-01) / 2.5 mL in 1 BOTTLEMarketed from Nov 26, 2024

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/ drops
Route
Ophthalmic
Labeler
Gland Pharma LimitedNDC labeler code 68083
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 218257
Marketing start
Listing expires
Identifiers
Product ID 68083-609_c63757a2-c757-4098-a29d-7a94104d050fSPL ID c63757a2-c757-4098-a29d-7a94104d050fSPL set ID 113abcc6-6e5c-4a57-ad6a-d69508ee990eRxCUI 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

N468083060901 followed by a unit qualifier and the quantity

Package 68083-0609-01. 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)

About NDC 68083-609

What is NDC 68083-609?
68083-609 is the product NDC for latanoprost, Latanoprost 50 ug/mL solution/ drops, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
latanoprost.
What is the active ingredient?
Latanoprost.
Who is the labeler?
Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for latanoprost?
14 other product NDCs are listed under this name. See all latanoprost 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 latanoprost NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
LatanoprostLatanoprost 50 ug/mLSolution/ dropsOphthalmicMicro Labs Limited42571-49942571-0499-06
LatanoprostLatanoprost 50 ug/mLSolution/ dropsOphthalmicSagent Pharmaceuticals25021-00125021-0001-02
latanoprostLatanoprost 50 ug/mLSolution/ dropsOphthalmicGLENMARK PHARMACEUTICALS INC68462-94468462-0944-03
LatanoprostLatanoprost 50 ug/mLSolution/ dropsOphthalmicNuCare Pharmaceuticals,Inc.68071-237668071-2376-02
LatanoprostLatanoprost 50 ug/mLSolution/ dropsOphthalmicSomerset Therapeutics, LLC70069-42170069-0421-0170069-0421-03
LatanoprostLatanoprost 50 ug/mLSolution/ dropsOphthalmicAurobindo Pharma Limited65862-87265862-0872-25
LatanoprostLatanoprost 50 ug/mLSolutionOphthalmicRising Pharma Holdings, Inc.64980-51664980-0516-25
LatanoprostLatanoprost 50 ug/mLSolution/ dropsOphthalmicBausch & Lomb Incorporated24208-46324208-0463-25
LatanoprostLatanoprost 50 ug/mLSolution/ dropsOphthalmicA-S Medication Solutions50090-192050090-1920-00
LatanoprostLatanoprost 50 ug/mLSolution/ dropsOphthalmicProficient Rx LP71205-15471205-0154-25

All 15 latanoprost NDCs

Other NDCs under ANDA 218257

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

FDA NDC Directory listings under ANDA 218257
ProductStrengthForm · routeLabelerProduct NDC
LatanoprostLatanoprost 50 ug/mLSolution/ dropsOphthalmicSagent Pharmaceuticals25021-001
latanoprostLatanoprost 50 ug/mLSolution/ dropsOphthalmicGLENMARK PHARMACEUTICALS INC68462-944

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