Prescription drug · ANDA
Brimonidine Tartrate and Timolol Maleate NDC 0781-7186
Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL · Solution/ drops · Ophthalmic · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-7186-70 | 0078171867000781718670 | 1 BOTTLE in 1 CARTON (0781-7186-70) / 10 mL in 1 BOTTLEMarketed from Apr 13, 2022 | |
| 0781-7186-75 | 0078171867500781718675 | 1 BOTTLE in 1 CARTON (0781-7186-75) / 5 mL in 1 BOTTLEMarketed from Apr 13, 2022 | |
| 0781-7186-85 | 0078171868500781718685 | 1 BOTTLE in 1 CARTON (0781-7186-85) / 15 mL in 1 BOTTLEMarketed from Apr 13, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Brimonidine Tartrate and Timolol Maleate
- Generic name (nonproprietary)
- brimonidine tartrate and timolol maleate
- Active ingredients
- Brimonidine tartrate — 2 mg/mLTimolol maleate — 5 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Sandoz IncNDC labeler code 0781
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091087
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 0781-7186_0b872a04-2f4a-4f0b-9fd9-d5151b36217eSPL ID 0b872a04-2f4a-4f0b-9fd9-d5151b36217eSPL set ID af21d2e5-0029-4889-ba93-6417baa91ce6RxCUI 861635UNII 4S9CL2DY2H, P8Y54F701R
- Pharmacologic class
- alpha-Adrenergic Agonist; 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
N400781718670followed by a unit qualifier and the quantityPackage 00781-7186-70. 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)
Brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. The IOP-lowering of brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day. Brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%/0.5% is a combination of brimonidine tartr…
Excerpt only. Read the full label for complete information.
About NDC 0781-7186
- What is NDC 0781-7186?
- 0781-7186 is the product NDC for Brimonidine Tartrate and Timolol Maleate, Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL solution/ drops, listed with the FDA by Sandoz Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Brimonidine Tartrate and Timolol Maleate.
- What is the active ingredient?
- Brimonidine tartrate, Timolol maleate.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Brimonidine Tartrate and Timolol Maleate?
- 8 other product NDCs are listed under this name. See all Brimonidine Tartrate and Timolol Maleate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Brimonidine Tartrate and Timolol Maleate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Brimonidine Tartrate and Timolol Maleate | Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-651 | 70069-0651-01 |
| Brimonidine Tartrate and Timolol Maleate | Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-652 | 70069-0652-01 |
| Brimonidine Tartrate and Timolol Maleate | Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-653 | 70069-0653-01 |
| Brimonidine Tartrate And Timolol Maleate | Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL | SolutionOphthalmic | Florida Pharmaceutical Products, LLC | 71921-188 | 71921-0188-0571921-0188-1071921-0188-15 |
| Brimonidine tartrate and Timolol maleate | Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | NorthStar RxLLC | 72603-931 | 72603-0931-0572603-0931-1072603-0931-15 |
| Brimonidine Tartrate and Timolol Maleate | Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Limited | 46708-706 | 46708-0706-0546708-0706-1046708-0706-15 |
| Brimonidine Tartrate and Timolol Maleate | Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Inc. | 62332-706 | 62332-0706-0562332-0706-1062332-0706-15 |
| Brimonidine Tartrate and Timolol Maleate | Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Upsher-Smith Laboratories, LLC | 0832-1425 | 00832-1425-0500832-1425-1000832-1425-15 |