Prescription drug · ANDA
Brimonidine Tartrate NDC 46708-749
Brimonidine tartrate 1 mg/mL · Solution/ drops · Ophthalmic · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-749-05 | 4670807490546708074905 | 1 BOTTLE in 1 CARTON (46708-749-05) / 5 mL in 1 BOTTLEMarketed from Aug 1, 2023 | |
| 46708-749-10 | 4670807491046708074910 | 1 BOTTLE in 1 CARTON (46708-749-10) / 10 mL in 1 BOTTLEMarketed from Aug 1, 2023 | |
| 46708-749-15 | 4670807491546708074915 | 1 BOTTLE in 1 CARTON (46708-749-15) / 15 mL in 1 BOTTLEMarketed from Aug 1, 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
- Generic name (nonproprietary)
- brimonidine tartrate
- Active ingredients
- Brimonidine tartrate — 1 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 216909
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 46708-749_ee26e0c9-a169-4842-ab0f-3c718bb14018SPL ID ee26e0c9-a169-4842-ab0f-3c718bb14018SPL set ID ee26e0c9-a169-4842-ab0f-3c718bb14018RxCUI 861204UNII 4S9CL2DY2H
- Pharmacologic class
- alpha-Adrenergic Agonist
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
N446708074905followed by a unit qualifier and the quantityPackage 46708-0749-05. 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 ophthalmic solution, 0.1% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension Brimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Excerpt only. Read the full label for complete information.
About NDC 46708-749
- What is NDC 46708-749?
- 46708-749 is the product NDC for Brimonidine Tartrate, Brimonidine tartrate 1 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.
- What is the active ingredient?
- Brimonidine tartrate.
- 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?
- 21 other product NDCs are listed under this name. See all Brimonidine Tartrate 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 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 | Brimonidine tartrate 1 mg/mL | Solution/ dropsOphthalmic | Upsher-Smith Laboratories, LLC | 0832-1435 | 00832-1435-0500832-1435-1000832-1435-15 |
| brimonidine tartrate | Brimonidine tartrate 1 mg/mL | Solution/ dropsOphthalmic | Micro Labs Limited | 42571-462 | 42571-0462-5642571-0462-92 |
| Brimonidine Tartrate | Brimonidine tartrate 1 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-626 | 68083-0626-0568083-0626-1068083-0626-15 |
| Brimonidine Tartrate | Brimonidine tartrate 1 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-566 | 70069-0566-01 |
| Brimonidine Tartrate | Brimonidine tartrate 1 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-567 | 70069-0567-01 |
| Brimonidine Tartrate | Brimonidine tartrate 1 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-568 | 70069-0568-01 |
| Brimonidine Tartrate | Brimonidine tartrate 1.5 mg/mL | Solution/ dropsOphthalmic | Upsher-Smith Laboratories, LLC | 0832-1420 | 00832-1420-0500832-1420-1000832-1420-15 |
| Brimonidine tartrate | Brimonidine tartrate 2 mg/mL | Solution/ dropsOphthalmic | Micro Labs Limited | 42571-419 | 42571-0419-5642571-0419-5742571-0419-92 |
| Brimonidine tartrate | Brimonidine tartrate 1 mg/mL | Solution/ dropsOphthalmic | Pacific Pharma, Inc. | 82182-321 | 82182-0321-0582182-0321-1082182-0321-15 |
| Brimonidine Tartrate | Brimonidine tartrate 1 mg/mL | Solution/ dropsOphthalmic | Apotex Corp. | 60505-0577 | 60505-0577-0160505-0577-0260505-0577-03 |
Other NDCs under ANDA 216909
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 | Brimonidine tartrate 1 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Inc. | 62332-749 |