Prescription drug · NDA
Zolymbus (Bimatoprost) NDC 82584-010
Bimatoprost .1 mg/g · Gel · Ophthalmic · Thea Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82584-010-10 | 8258400101082584001010 | 1 POUCH in 1 CARTON (82584-010-10) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .3 g in 1 VIAL, SINGLE-DOSEMarketed from Feb 26, 2026 · Sample package | |
| 82584-010-30 | 8258400103082584001030 | 3 POUCH in 1 CARTON (82584-010-30) / 10 VIAL, SINGLE-DOSE in 1 POUCH (82584-010-81) / .3 g in 1 VIAL, SINGLE-DOSEMarketed from Feb 26, 2026 | |
| 82584-010-35 | 8258400103582584001035 | 3 POUCH in 1 CARTON (82584-010-35) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .3 g in 1 VIAL, SINGLE-DOSEMarketed from Feb 26, 2026 · 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)
- Zolymbus
- Generic name (nonproprietary)
- bimatoprost
- Active ingredients
- Bimatoprost — .1 mg/g
- Dosage form
- Gel
- Route
- Ophthalmic
- Labeler
- Thea Pharma Inc.NDC labeler code 82584
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217307
- Marketing start
- Listing expires
- Other FDA classes
- Prostaglandins (Chemical structure)
- Identifiers
- Product ID 82584-010_4badbaf4-122e-3878-e063-6294a90ab4baSPL ID 4badbaf4-122e-3878-e063-6294a90ab4baSPL set ID f4504a0c-7998-4084-9e05-f999f1d051edRxCUI 2725168, 2725620UNII QXS94885MZ
- Pharmacologic class
- Prostaglandin Analog
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
N482584001010followed by a unit qualifier and the quantityPackage 82584-0010-10. 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)
ZOLYMBUS™ is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ZOLYMBUS™ is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Excerpt only. Read the full label for complete information.
About NDC 82584-010
- What is NDC 82584-010?
- 82584-010 is the product NDC for Zolymbus (bimatoprost), Bimatoprost .1 mg/g gel, listed with the FDA by Thea Pharma Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zolymbus (Bimatoprost).
- What is the active ingredient?
- Bimatoprost.
- Who is the labeler?
- Thea Pharma Inc., NDC labeler code 82584. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zolymbus?
- 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.