Prescription drug · NDA
Timoptic-XE (Timolol maleate) NDC 24208-816
Timolol maleate 5 mg/mL · Solution · Ophthalmic · Bausch & Lomb Incorporated
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24208-816-05 | 2420808160524208081605 | 1 BOTTLE, DISPENSING in 1 CARTON (24208-816-05) / 5 mL in 1 BOTTLE, DISPENSINGMarketed from May 31, 2016 |
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)
- Timoptic-XE
- Generic name (nonproprietary)
- timolol maleate
- Active ingredients
- Timolol maleate — 5 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Bausch & Lomb IncorporatedNDC labeler code 24208
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020330
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 24208-816_cb6890c5-7788-453b-910d-10c2bee17d04SPL ID cb6890c5-7788-453b-910d-10c2bee17d04SPL set ID a4d03de7-06b7-4cfc-9d1b-616969df209cRxCUI 313407, 313408, 861420, 861422UNII 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
N424208081605followed by a unit qualifier and the quantityPackage 24208-0816-05. 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 TIMOPTIC-XE Sterile Ophthalmic Gel Forming Solution 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 24208-816
- What is NDC 24208-816?
- 24208-816 is the product NDC for Timoptic-XE (timolol maleate), Timolol maleate 5 mg/mL solution, listed with the FDA by Bausch & Lomb Incorporated. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Timoptic-XE (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 Timoptic-XE?
- 1 other product NDC are listed under this name. See all Timoptic-XE NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Timoptic-XE products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Timoptic-XEtimolol maleate | Timolol maleate 2.5 mg/mL | SolutionOphthalmic | Bausch & Lomb Incorporated | 24208-814 | 24208-0814-25 |
Other NDCs under NDA 020330
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 2.5 mg/mL | SolutionOphthalmic | Bausch & Lomb Americas Inc. | 82260-818 |
| Timolol Maleate | Timolol maleate 5 mg/mL | SolutionOphthalmic | Bausch & Lomb Americas Inc. | 82260-819 |
| Timoptic-XEtimolol maleate | Timolol maleate 2.5 mg/mL | SolutionOphthalmic | Bausch & Lomb Incorporated | 24208-814 |