Prescription drug · NDA
Istalol (Timolol maleate) NDC 24208-004
Timolol maleate 5 mg/mL · Solution/ drops · Ophthalmic · Bausch & Lomb Incorporated
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24208-004-01 | 2420800040124208000401 | 1 BOTTLE, DROPPER in 1 CARTON (24208-004-01) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from Aug 2, 2004 | |
| 24208-004-02 | 2420800040224208000402 | 1 BOTTLE, DROPPER in 1 CARTON (24208-004-02) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from Aug 2, 2004 | |
| 24208-004-03 | 2420800040324208000403 | 1 BOTTLE, DROPPER in 1 CARTON (24208-004-03) / 5 mL in 1 BOTTLE, DROPPERMarketed from Aug 2, 2004 |
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)
- Istalol
- Generic name (nonproprietary)
- timolol maleate
- Active ingredients
- Timolol maleate — 5 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Bausch & Lomb IncorporatedNDC labeler code 24208
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021516
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 24208-004_25b64789-6ef9-4c49-e063-6294a90a0ec4SPL ID 25b64789-6ef9-4c49-e063-6294a90a0ec4SPL set ID 258bbc8d-00ee-45b0-ac35-6f16c4e8d45fRxCUI 1992299, 1992300UNII P8Y54F701R
- 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
N424208000401followed by a unit qualifier and the quantityPackage 24208-0004-01. 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)
ISTALOL ® is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. ISTALOL is a beta adrenergic blocker indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 24208-004
- What is NDC 24208-004?
- 24208-004 is the product NDC for Istalol (timolol maleate), Timolol maleate 5 mg/mL solution/ drops, listed with the FDA by Bausch & Lomb Incorporated. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Istalol (Timolol Maleate).
- What is the active ingredient?
- Timolol maleate.
- Who is the labeler?
- Bausch & Lomb Incorporated, NDC labeler code 24208. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Istalol?
- 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.
Other NDCs under NDA 021516
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 |
|---|---|---|---|---|
| Timolol Maleate | Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Americas Inc. | 82260-045 |