Prescription drug · ANDA
Brimonidine Tartrate ophthalmic solution, 0.15% NDC 46708-661
Brimonidine tartrate 1.5 mg/mL · Solution/ drops · Ophthalmic · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-661-05 | 4670806610546708066105 | 1 BOTTLE in 1 CARTON (46708-661-05) / 5 mL in 1 BOTTLEMarketed from Mar 29, 2023 | |
| 46708-661-10 | 4670806611046708066110 | 1 BOTTLE in 1 CARTON (46708-661-10) / 10 mL in 1 BOTTLEMarketed from Mar 29, 2023 | |
| 46708-661-15 | 4670806611546708066115 | 1 BOTTLE in 1 CARTON (46708-661-15) / 15 mL in 1 BOTTLEMarketed from Mar 29, 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 ophthalmic solution, 0.15%
- Generic name (nonproprietary)
- brimonidine tartrate ophthalmic solution, 0.15%
- Active ingredients
- Brimonidine tartrate — 1.5 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 215225
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 46708-661_e1ea003e-3dd9-41c7-9119-d1f209b9820bSPL ID e1ea003e-3dd9-41c7-9119-d1f209b9820bSPL set ID e1ea003e-3dd9-41c7-9119-d1f209b9820bRxCUI 861208UNII 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
N446708066105followed by a unit qualifier and the quantityPackage 46708-0661-05. 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, 0.15% 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 46708-661
- What is NDC 46708-661?
- 46708-661 is the product NDC for Brimonidine Tartrate ophthalmic solution, 0.15%, Brimonidine tartrate 1.5 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 ophthalmic solution, 0.15%.
- 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 ophthalmic solution, 0.15%?
- 1 other product NDC are listed under this name. See all Brimonidine Tartrate ophthalmic solution, 0.15% 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 ophthalmic solution, 0.15% 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 ophthalmic solution, 0.15% | Brimonidine tartrate 1.5 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Inc. | 62332-661 | 62332-0661-0562332-0661-1062332-0661-15 |
Other NDCs under ANDA 215225
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 ophthalmic solution, 0.15% | Brimonidine tartrate 1.5 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Inc. | 62332-661 |