Prescription drug · ANDA
Brimonidine Tartrate NDC 14445-400
Brimonidine tartrate 2 mg/mg · Solution/ drops · Ophthalmic · Indoco Remedies Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 14445-400-05 | 1444504000514445040005 | 5 mg in 1 BOTTLE, PLASTIC (14445-400-05)Marketed from Jan 1, 2015 | |
| 14445-400-10 | 1444504001014445040010 | 10 mg in 1 BOTTLE, PLASTIC (14445-400-10)Marketed from Jan 1, 2015 | |
| 14445-400-15 | 1444504001514445040015 | 15 mg in 1 BOTTLE, PLASTIC (14445-400-15)Marketed from Jan 1, 2015 |
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/mg
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Indoco Remedies LimitedNDC labeler code 14445
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091691
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 14445-400_383421a5-5d33-4f15-88f4-8b66fcbfac71SPL ID 383421a5-5d33-4f15-88f4-8b66fcbfac71SPL set ID 383421a5-5d33-4f15-88f4-8b66fcbfac71RxCUI 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
N414445040005followed by a unit qualifier and the quantityPackage 14445-0400-05. 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, 0.2% is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of Brimonidine tartrate ophthalmic solution, 0.2% 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 14445-400
- What is NDC 14445-400?
- 14445-400 is the product NDC for Brimonidine Tartrate, Brimonidine tartrate 2 mg/mg solution/ drops, listed with the FDA by Indoco Remedies 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?
- Indoco Remedies Limited, NDC labeler code 14445. 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 091691
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 2 mg/mg | Solution/ dropsOphthalmic | Florida Pharmaceutical Products, LLC | 71921-185 |