NDC codes

FDA NDC Directory
Product NDC (as listed)63187-669Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0669Add 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
63187-669-35631870669351 TUBE in 1 CARTON (63187-669-35) / 3.5 g in 1 TUBEMarketed from Dec 1, 2018

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)
Neomycin and Polymyxin B Sulfates and Dexamethasone
Generic name (nonproprietary)
neomycin sulfate, polymyxin b sulfate, and dexamethasone
Active ingredients
Neomycin sulfate — 3.5 mg/gPolymyxin b sulfate — 10000 [USP'U]/gDexamethasone — 1 mg/g
Dosage form
Ointment
Route
Ophthalmic
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 064063
Marketing start
Listing expires
Other FDA classes
Aminoglycosides (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)Polymyxins (Chemical structure)
Identifiers
Product ID 63187-669_84f8a211-aaba-4d86-b71c-9a0632217c9eSPL ID 84f8a211-aaba-4d86-b71c-9a0632217c9eSPL set ID 21c9b34c-af88-4c9e-9b6c-32d78d34ba7eRxCUI 309679UNII 057Y626693, 19371312D4, 7S5I7G3JQLUPC 0363187669355
Pharmacologic class
Aminoglycoside Antibacterial; Corticosteroid; Polymyxin-class Antibacterial

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

N463187066935 followed by a unit qualifier and the quantity

Package 63187-0669-35. 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 steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain cases of infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 064063

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

FDA NDC Directory listings under ANDA 064063
ProductStrengthForm · routeLabelerProduct NDC
Neomycin And Polymyxin B Sulfates And DexamethasoneNeomycin sulfate 3.5 mg/g + 2 more ingredientsOintmentOphthalmicAdvanced Rx Pharmacy of Tennessee, LLC80425-0229
Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate, and dexamethasoneNeomycin sulfate 3.5 mg/g + 2 more ingredientsOintmentOphthalmicBausch & Lomb Incorporated24208-795
Neo/Poly-B/Dex Ophth OintPolymyxin b sulfate 10000 [USP'U]/g + 2 more ingredientsOintmentOphthalmicDirect_Rx72189-532
Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate, and dexamethasoneNeomycin sulfate 3.5 mg/g + 2 more ingredientsOintmentOphthalmicA-S Medication Solutions50090-6181
Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate, and dexamethasoneNeomycin sulfate 3.5 mg/g + 2 more ingredientsOintmentOphthalmicNuCare Pharmaceuticals,Inc.68071-2428
Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate, and dexamethasoneNeomycin sulfate 3.5 mg/g + 2 more ingredientsOintmentOphthalmicPreferred Pharmaceuticals Inc.68788-8748

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