Prescription drug · NDA
Betimol (Timolol) NDC 82584-001
Timolol 2.56 mg/mL · Solution/ drops · Ophthalmic · Thea Pharma Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Betimol
- Generic name (nonproprietary)
- timolol
- Active ingredients
- Timolol — 2.56 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Thea Pharma Inc.NDC labeler code 82584
- 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 82584-001_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.
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.
About NDC 82584-001
- What is NDC 82584-001?
- 82584-001 is the product NDC for Betimol (timolol), Timolol 2.56 mg/mL solution/ drops, listed with the FDA by Thea Pharma Inc..
- What drug is associated with this NDC?
- Betimol (Timolol).
- What is the active ingredient?
- Timolol.
- 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 Betimol?
- 1 other product NDC are listed under this name. See all Betimol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Betimol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Betimoltimolol | Timolol 5.12 mg/mL | Solution/ dropsOphthalmic | Thea Pharma Inc. | 82584-002 | 82584-0002-05 |
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 5.12 mg/mL | Solution/ dropsOphthalmic | Thea Pharma Inc. | 82584-002 |