NDC codes

FDA NDC Directory
Product NDC (as listed)83368-075Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83368-0075Add 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
83368-075-3083368007530833680075306 POUCH in 1 CARTON (83368-075-30) / 5 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USEMarketed from Mar 25, 2024
83368-075-3183368007531833680075311 POUCH in 1 CARTON (83368-075-31) / 5 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USEMarketed from Sep 25, 2024 · Sample package

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)
Ryzumvi
Generic name (nonproprietary)
phentolamine mesylate
Active ingredients
Phentolamine mesylate — 10 mg/mL
Dosage form
Solution/ drops
Route
Ophthalmic
Labeler
Oyster Point Pharma, Inc.NDC labeler code 83368
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 217064
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Antagonists (Mechanism)
Identifiers
Product ID 83368-075_5652e1c3-6e06-457d-86f5-b05d5b399878SPL ID 5652e1c3-6e06-457d-86f5-b05d5b399878SPL set ID 96bb1e53-c2cc-4e60-a21a-db0269c371bfRxCUI 2677793, 2677798UNII Y7543E5K9T
Pharmacologic class
alpha-Adrenergic Blocker

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

N483368007530 followed by a unit qualifier and the quantity

Package 83368-0075-30. 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)

RYZUMVI is indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic agents (e.g., tropicamide). RYZUMVI is an alpha-adrenergic blocker indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic agents (e.g., tropicamide). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83368-075

What is NDC 83368-075?
83368-075 is the product NDC for Ryzumvi (phentolamine mesylate), Phentolamine mesylate 10 mg/mL solution/ drops, listed with the FDA by Oyster Point Pharma, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ryzumvi (Phentolamine mesylate).
What is the active ingredient?
Phentolamine mesylate.
Who is the labeler?
Oyster Point Pharma, Inc., NDC labeler code 83368. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ryzumvi?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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