Prescription drug · NDA
Tyrvaya (Varenicline) NDC 73521-030
Varenicline tartrate .03 mg/.05mL · Spray · Nasal · Oyster Point Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73521-030-02 | 7352100300273521003002 | 2 BOTTLE, PUMP in 1 CARTON (73521-030-02) / 4.2 mL in 1 BOTTLE, PUMPMarketed from Oct 20, 2021 | |
| 73521-030-90 | 7352100309073521003090 | 1 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
N473521003002followed by a unit qualifier and the quantityPackage 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.