Prescription drug · ANDA
Brimonidine Tartrate and Timolol Maleate NDC 46708-706
Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL · Solution/ drops · Ophthalmic · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-706-05 | 4670807060546708070605 | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Aug 25, 2023 | |
| 46708-706-10 | 4670807061046708070610 | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from Aug 25, 2023 | |
| 46708-706-15 | 4670807061546708070615 | 1 BOTTLE, DROPPER in 1 CARTON (46708-706-15) / 15 mL in 1 BOTTLE, DROPPERMarketed from Aug 25, 2023 |
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)
- 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
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215230
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 46708-706_b5d560b6-847e-4f09-b1ef-22e4deb8a206SPL ID b5d560b6-847e-4f09-b1ef-22e4deb8a206SPL set ID b5d560b6-847e-4f09-b1ef-22e4deb8a206RxCUI 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
N446708070605followed by a unit qualifier and the quantityPackage 46708-0706-05. 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)
Brimonidine tartrate and timolol maleate ophthalmic solution 0.2% /0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor 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 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 …
Excerpt only. Read the full label for complete information.
About NDC 46708-706
- What is NDC 46708-706?
- 46708-706 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 Alembic Pharmaceuticals Limited. 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?
- 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 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 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 |
| Brimonidine Tartrate and Timolol Maleate | Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Sandoz Inc | 0781-7186 | 00781-7186-7000781-7186-7500781-7186-85 |
Other NDCs under ANDA 215230
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 |
|---|---|---|---|---|
| Brimonidine Tartrate and Timolol Maleate | Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Inc. | 62332-706 |