Prescription drug · ANDA
triamcinolone acetonide NDC 0168-0003
Triamcinolone acetonide .25 mg/g · Cream · Topical · E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0168-0003-15 | 00168000315 | 1 TUBE in 1 CARTON (0168-0003-15) / 15 g in 1 TUBEMarketed from Mar 9, 1978 | |
| 0168-0003-80 | 00168000380 | 1 TUBE in 1 CARTON (0168-0003-80) / 80 g in 1 TUBEMarketed from Mar 9, 1978 |
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)
- triamcinolone acetonide
- Generic name (nonproprietary)
- triamcinolone acetonide
- Active ingredients
- Triamcinolone acetonide — .25 mg/g
- Dosage form
- Cream
- Route
- Topical
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 085692
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0168-0003_c8c77210-0a99-47c9-8fe3-0f1531110ffaSPL ID c8c77210-0a99-47c9-8fe3-0f1531110ffaSPL set ID 92a1ded0-8e1a-4994-9c8a-89e84fc85c94RxCUI 1014314, 1085644, 1085686UNII F446C597KAUPC 0301680004150, 0301680003153, 0301680002156
- Pharmacologic class
- Corticosteroid
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
N400168000315followed by a unit qualifier and the quantityPackage 00168-0003-15. 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)
INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 085692
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 |
|---|---|---|---|---|
| Triamcinolone Acetonide | Triamcinolone acetonide .25 mg/g | CreamTopical | Proficient Rx LP | 63187-214 |
| triamcinolone acetonide | Triamcinolone acetonide 1 mg/g | CreamTopical | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 0168-0004 |
| triamcinolone acetonide | Triamcinolone acetonide .25 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8515 |
| triamcinolone acetonide | Triamcinolone acetonide 5 mg/g | CreamTopical | Preferred Pharmaceuticals Inc. | 68788-8892 |
| Triamcinolone Acetonide | Triamcinolone acetonide 1 mg/g | CreamTopical | DIRECTRX | 61919-650 |
| Triamcinolone Acetonide | Triamcinolone acetonide 1 mg/g | CreamTopical | Proficient Rx LP | 63187-053 |
| triamcinolone acetonide | Triamcinolone acetonide .25 mg/g | CreamTopical | A-S Medication Solutions | 50090-0293 |
| triamcinolone acetonide | Triamcinolone acetonide 5 mg/g | CreamTopical | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 0168-0002 |