Prescription drug · ANDA
Fluocinolone Acetonide NDC 71335-2884
Fluocinolone acetonide .11 mg/mL · Oil · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2884-1 | 7133528840171335288401 | 1 BOTTLE in 1 CARTON (71335-2884-1) / 118.28 mL in 1 BOTTLEMarketed from Nov 10, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Fluocinolone Acetonide
- Generic name (nonproprietary)
- fluocinolone acetonide
- Active ingredients
- Fluocinolone acetonide — .11 mg/mL
- Dosage form
- Oil
- Route
- Topical
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212760
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 71335-2884_5dbd33e6-5805-49f1-af6c-fbc7c0211847SPL ID 5dbd33e6-5805-49f1-af6c-fbc7c0211847SPL set ID 8b6cbb2e-9c9a-4bef-bf06-f62bdbed8c8bRxCUI 1191307UNII 0CD5FD6S2M
- 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
N471335288401followed by a unit qualifier and the quantityPackage 71335-2884-01. 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)
Fluocinolone acetonide topical oil, 0.01% is a corticosteroid indicated for the topical treatment of atopic dermatitis in adult patients ( 1.1 ) topical treatment of moderato to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks ( 1.2 ) Limitations of Use: Apply the least amount to cover affected areas. Discontinue when disease is controlled. ( 1.3 ) Do not use in the diaper area. ( 1.3 ) Do not use on the face, axillae, or groin. ( 1.3 , 6.2 , 8.4 ) 1.1 Adult Patients with Atopic Dermatitis Fluocinolone acetonide topical oil, 0.01% is indicated for the topical treatment of atopic dermatitis in adult patients. 1.2 Pediatric Patients with Atopic Dermatitis Flu…
Excerpt only. Read the full label for complete information.
About NDC 71335-2884
- What is NDC 71335-2884?
- 71335-2884 is the product NDC for Fluocinolone Acetonide, Fluocinolone acetonide .11 mg/mL oil, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluocinolone Acetonide.
- What is the active ingredient?
- Fluocinolone acetonide.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fluocinolone Acetonide?
- 31 other product NDCs are listed under this name. See all Fluocinolone Acetonide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fluocinolone Acetonide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| fluocinolone acetonide | Fluocinolone acetonide .1 mg/g | CreamTopical | ANI Pharmaceuticals, Inc. | 62559-288 | 62559-0288-1562559-0288-60 |
| fluocinolone acetonide | Fluocinolone acetonide .25 mg/g | CreamTopical | ANI Pharmaceuticals, Inc. | 62559-289 | 62559-0289-1562559-0289-60 |
| Fluocinolone Acetonide | Fluocinolone acetonide .25 mg/g | OintmentTopical | ANI Pharmaceuticals, Inc. | 62559-299 | 62559-0299-1562559-0299-60 |
| Fluocinolone Acetonide | Fluocinolone acetonide .11 mg/mL | OilTopical | Quagen Pharmaceuticals LLC | 70752-156 | 70752-0156-06 |
| Fluocinolone Acetonide | Fluocinolone acetonide .11 mg/mL | OilTopical | Quagen Pharmaceuticals LLC | 70752-158 | 70752-0158-06 |
| Fluocinolone Acetonide | Fluocinolone acetonide .11 mg/mL | OilAuricular (Otic) | Quagen Pharmaceuticals LLC | 70752-159 | 70752-0159-20 |
| Fluocinolone Acetonide | Fluocinolone acetonide .11 mg/mL | OilAuricular (Otic) | Bryant Ranch Prepack | 71335-2879 | 71335-2879-01 |
| Fluocinolone Acetonide | Fluocinolone acetonide .11 mg/mL | OilTopical | Bryant Ranch Prepack | 71335-2883 | 71335-2883-01 |
| Fluocinolone Acetonide | Fluocinolone acetonide .11 mg/mL | OilTopical | Bryant Ranch Prepack | 72162-2319 | 72162-2319-02 |
| Fluocinolone Acetonide | Fluocinolone acetonide .11 mg/mL | OilAuricular (Otic) | Bryant Ranch Prepack | 72162-2320 | 72162-2320-02 |
Other NDCs under ANDA 212760
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 |
|---|---|---|---|---|
| Fluocinolone Acetonide | Fluocinolone acetonide .11 mg/mL | OilTopical | Quagen Pharmaceuticals LLC | 70752-156 |
| Fluocinolone Acetonide | Fluocinolone acetonide .11 mg/mL | OilTopical | Bryant Ranch Prepack | 72162-2319 |