Prescription drug · ANDA
Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% NDC 46708-545
Timolol maleate 2.5 mg/mL · Solution/ drops · Ophthalmic · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-545-05 | 4670805450546708054505 | 1 BOTTLE in 1 CARTON (46708-545-05) / 5 mL in 1 BOTTLEMarketed from Nov 22, 2020 |
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)
- Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%
- Generic name (nonproprietary)
- timolol maleate ophthalmic gel forming solution, 0.25%
- Active ingredients
- Timolol maleate — 2.5 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212942
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 46708-545_9a5aab8f-59b9-4d73-82c4-dc5b8fa8119eSPL ID 9a5aab8f-59b9-4d73-82c4-dc5b8fa8119eSPL set ID 9a5aab8f-59b9-4d73-82c4-dc5b8fa8119eRxCUI 313407, 313408UNII 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
N446708054505followed by a unit qualifier and the quantityPackage 46708-0545-05. 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 Timolol maleate 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 46708-545
- What is NDC 46708-545?
- 46708-545 is the product NDC for Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%, Timolol maleate 2.5 mg/mL solution/ drops, listed with the FDA by Alembic Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%.
- What is the active ingredient?
- Timolol maleate.
- Who is the labeler?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%?
- 3 other product NDCs are listed under this name. See all Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Timolol Maleate Ophthalmic Gel Forming Solution 0.25% | Timolol maleate 2.5 mg/mL | Solution/ dropsOphthalmic | NorthStar RxLLC | 72603-162 | 72603-0162-01 |
| Timolol Maleate Ophthalmic Gel Forming Solution 0.25% | Timolol maleate 2.5 mg/mL | Solution/ dropsOphthalmic | Dr. Reddy's Laboratories, Inc. | 43598-747 | 43598-0747-11 |
| Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% | Timolol maleate 2.5 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Inc. | 62332-545 | 62332-0545-05 |
Other NDCs under ANDA 212942
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 Ophthalmic Gel Forming Solution, 0.25% | Timolol maleate 2.5 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Inc. | 62332-545 |
| Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% | Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Limited | 46708-546 |
| Timolol Maleate Ophthalmic Gel Forming Solution, 0.5% | Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Inc. | 62332-546 |