NDC codes

FDA NDC Directory
Product NDC (as listed)73521-030Labeler and product segments. Claims need a package NDC.
Product NDC at billing width73521-0030Add 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
73521-030-0273521003002735210030022 BOTTLE, PUMP in 1 CARTON (73521-030-02) / 4.2 mL in 1 BOTTLE, PUMPMarketed from Oct 20, 2021
73521-030-9073521003090735210030901 BOTTLE, PUMP in 1 CARTON (73521-030-90) / 4.2 mL in 1 BOTTLE, PUMPMarketed from Oct 20, 2021 · 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)
Tyrvaya
Generic name (nonproprietary)
varenicline
Active ingredients
Varenicline tartrate — .03 mg/.05mL
Dosage form
Spray
Route
Nasal
Labeler
Oyster Point Pharma, Inc.NDC labeler code 73521
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 213978
Marketing start
Listing expires
Other FDA classes
Cholinergic Agonists (Mechanism)Partial Cholinergic Nicotinic Agonists (Mechanism)
Identifiers
Product ID 73521-030_23d5d756-b3a5-4504-b88c-cf0de54ece1fSPL ID 23d5d756-b3a5-4504-b88c-cf0de54ece1f
Pharmacologic class
Cholinergic Receptor Agonist; Partial Cholinergic Nicotinic Agonist

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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N473521003002 followed by a unit qualifier and the quantity

Package 73521-0030-02. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 73521-030

What is NDC 73521-030?
73521-030 is the product NDC for Tyrvaya (varenicline), Varenicline tartrate .03 mg/.05mL spray, 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?
Tyrvaya (Varenicline).
What is the active ingredient?
Varenicline tartrate.
Who is the labeler?
Oyster Point Pharma, Inc., NDC labeler code 73521. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tyrvaya?
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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