Prescription drug · ANDA
Brimonidine tartrate NDC 42571-419
Brimonidine tartrate 2 mg/mL · Solution/ drops · Ophthalmic · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-419-56 | 4257104195642571041956 | 1 BOTTLE, DROPPER in 1 CARTON (42571-419-56) / 10 mL in 1 BOTTLE, DROPPERMarketed from Apr 1, 2024 | |
| 42571-419-57 | 4257104195742571041957 | 1 BOTTLE, DROPPER in 1 CARTON (42571-419-57) / 15 mL in 1 BOTTLE, DROPPERMarketed from Apr 1, 2024 | |
| 42571-419-92 | 4257104199242571041992 | 1 BOTTLE, DROPPER in 1 CARTON (42571-419-92) / 5 mL in 1 BOTTLE, DROPPERMarketed from Apr 1, 2024 |
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 — 2 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Micro Labs LimitedNDC labeler code 42571
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217846
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 42571-419_3aac4288-aa47-296b-e063-6294a90a8fd8SPL ID 3aac4288-aa47-296b-e063-6294a90a8fd8SPL set ID 75c5f708-1afb-4505-94a6-a2c0afb0aedcRxCUI 861200UNII 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
N442571041956followed by a unit qualifier and the quantityPackage 42571-0419-56. 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 0.2% is indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of brimonidine tartrate ophthalmic solution diminishes over time in some patients. This loss of effect appears with a variable time of onset in each patient and should be closely monitored. Brimonidine tartrate ophthalmic solution 0.2% is an alpha adrenergic agonist indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 42571-419
- What is NDC 42571-419?
- 42571-419 is the product NDC for Brimonidine tartrate, Brimonidine tartrate 2 mg/mL solution/ drops, listed with the FDA by Micro Labs 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?
- Micro Labs Limited, NDC labeler code 42571. 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 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 |