Prescription drug · NDA
Qlosi (Pilocarpine hydrochloride) NDC 83661-018
Pilocarpine hydrochloride 4 mg/mL · Solution · Ophthalmic · Orasis Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83661-018-10 | 8366100181083661001810 | 10 VIAL, SINGLE-USE in 1 BOX (83661-018-10) / .4 mL in 1 VIAL, SINGLE-USEMarketed from Jan 15, 2025 | |
| 83661-018-20 | 8366100182083661001820 | 20 VIAL, SINGLE-USE in 1 BOX (83661-018-20) / .4 mL in 1 VIAL, SINGLE-USEMarketed from Jan 15, 2025 | |
| 83661-018-30 | 8366100183083661001830 | 30 VIAL, SINGLE-USE in 1 BOX (83661-018-30) / .4 mL in 1 VIAL, SINGLE-USEMarketed from Oct 15, 2024 | |
| 83661-018-60 | 8366100186083661001860 | 60 VIAL, SINGLE-USE in 1 BOX (83661-018-60) / .4 mL in 1 VIAL, SINGLE-USEMarketed from Jan 15, 2025 |
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)
- Qlosi
- Generic name (nonproprietary)
- pilocarpine hydrochloride
- Active ingredients
- Pilocarpine hydrochloride — 4 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Orasis Pharmaceuticals, Inc.NDC labeler code 83661
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217836
- Marketing start
- Listing expires
- Other FDA classes
- Cholinergic Agonists (Mechanism)Cholinergic Muscarinic Agonists (Mechanism)
- Identifiers
- Product ID 83661-018_35bee113-ab9f-605d-e063-6394a90ac5a2SPL ID 35bee113-ab9f-605d-e063-6394a90ac5a2SPL set ID 4ee2a840-1203-473a-aa42-316a3ddf2fbeRxCUI 2695439, 2695445UNII 0WW6D218XJUPC 0383661018301
- Pharmacologic class
- Cholinergic Receptor 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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N483661001810followed by a unit qualifier and the quantityPackage 83661-0018-10. 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)
QLOSI is indicated for the treatment of presbyopia in adults. QLOSI is a cholinergic agonist indicated for the treatment of presbyopia in adults. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 83661-018
- What is NDC 83661-018?
- 83661-018 is the product NDC for Qlosi (pilocarpine hydrochloride), Pilocarpine hydrochloride 4 mg/mL solution, listed with the FDA by Orasis Pharmaceuticals, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Qlosi (Pilocarpine Hydrochloride).
- What is the active ingredient?
- Pilocarpine hydrochloride.
- Who is the labeler?
- Orasis Pharmaceuticals, Inc., NDC labeler code 83661. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Qlosi?
- 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.