Prescription drug · NDA
Betimol (timolol) NDC 82584-002
Timolol 5.12 mg/mL · Solution/ drops · Ophthalmic · Thea Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82584-002-05 | 82584000205 | 1 BOTTLE, DROPPER in 1 CARTON (82584-002-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Nov 15, 2022 |
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)
- Betimol
- Generic name (nonproprietary)
- timolol
- Active ingredients
- Timolol — 5.12 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Thea Pharma Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020439
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 82584-002_3891d7f3-d858-9f71-e063-6394a90af95bSPL ID 3891d7f3-d858-9f71-e063-6394a90af95bSPL set ID 3ae775f4-340c-4bf4-aa49-8a31daba0f8bRxCUI 208560, 1992305, 2702393, 2702398UNII 817W3C6175UPC 0382584002053
- Pharmacologic class
- beta-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
N482584000205followed by a unit qualifier and the quantityPackage 82584-0002-05. 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)
INDICATIONS AND USAGE Betimol ® is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020439
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Betimoltimolol | Timolol 2.56 mg/mL | Solution/ dropsOphthalmic | Thea Pharma Inc. | 82584-001 |