Prescription drug · NDA
Mirvaso (brimonidine tartrate) NDC 0299-5980
Brimonidine tartrate 5 mg/g · Gel · Topical · Galderma Laboratories, L.P.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0299-5980-00 | 00299598000 | 1 TUBE in 1 BLISTER PACK (0299-5980-00) / 2 g in 1 TUBEMarketed from Aug 23, 2013 · Sample package | |
| 0299-5980-02 | 00299598002 | 2 g in 1 TUBE (0299-5980-02)Marketed from Aug 23, 2013 · Sample package | |
| 0299-5980-30 | 00299598030 | 30 g in 1 TUBE (0299-5980-30)Marketed from Aug 23, 2013 | |
| 0299-5980-35 | 00299598035 | 1 BOTTLE, PUMP in 1 CARTON (0299-5980-35) / 30 g in 1 BOTTLE, PUMPMarketed from Aug 23, 2013 | |
| 0299-5980-45 | 00299598045 | 45 g in 1 TUBE (0299-5980-45)Marketed from Aug 23, 2013 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Mirvaso
- Generic name (nonproprietary)
- brimonidine tartrate
- Active ingredients
- Brimonidine tartrate — 5 mg/g
- Dosage form
- Gel
- Route
- Topical
- Labeler
- Galderma Laboratories, L.P.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204708
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 0299-5980_253bf4a2-3c4d-f4af-e063-6394a90a0b0aSPL ID 253bf4a2-3c4d-f4af-e063-6394a90a0b0aSPL set ID f6a4353f-ae69-4214-901f-e5d42a6fbde7RxCUI 1437707, 1437709UNII 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400299598000followed by a unit qualifier and the quantityPackage 00299-5980-00. 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)
MIRVASO (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older. MIRVASO (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older.( 1 )
Excerpt only. Read the full label for complete information.