Prescription drug · ANDA
Brimonidine Tartrate NDC 68083-626
Brimonidine tartrate 1 mg/mL · Solution/ drops · Ophthalmic · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-626-05 | 6808306260568083062605 | 1 BOTTLE in 1 CARTON (68083-626-05) / 5 mL in 1 BOTTLEMarketed from Mar 11, 2026 | |
| 68083-626-10 | 6808306261068083062610 | 1 BOTTLE in 1 CARTON (68083-626-10) / 10 mL in 1 BOTTLEMarketed from Mar 11, 2026 | |
| 68083-626-15 | 6808306261568083062615 | 1 BOTTLE in 1 CARTON (68083-626-15) / 15 mL in 1 BOTTLEMarketed from Mar 11, 2026 |
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
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219219
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 68083-626_d45de474-a50b-4bb3-a833-3b163803a9fcSPL ID d45de474-a50b-4bb3-a833-3b163803a9fcSPL set ID e4b04ef1-6586-4386-a844-2c5fc3bd4a8fRxCUI 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
N468083062605followed by a unit qualifier and the quantityPackage 68083-0626-05. 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 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 agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 68083-626
- What is NDC 68083-626?
- 68083-626 is the product NDC for Brimonidine Tartrate, Brimonidine tartrate 1 mg/mL solution/ drops, listed with the FDA by Gland Pharma 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?
- Gland Pharma Limited, NDC labeler code 68083. 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 | 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 |
| Brimonidine Tartrate | Brimonidine tartrate 1 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Limited | 46708-749 | 46708-0749-0546708-0749-1046708-0749-15 |