Prescription drug · ANDA
Hydrocortisone Butyrate NDC 83148-012
Hydrocortisone butyrate 1 mg/mL · Lotion · Topical · The J. Molner Company LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83148-012-02 | 83148001202 | 1 BOTTLE in 1 CARTON (83148-012-02) / 59 mL in 1 BOTTLEMarketed from Nov 6, 2023 | |
| 83148-012-04 | 83148001204 | 1 BOTTLE in 1 CARTON (83148-012-04) / 118 mL in 1 BOTTLEMarketed from Nov 6, 2023 |
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)
- Hydrocortisone Butyrate
- Generic name (nonproprietary)
- hydrocortisone butyrate
- Active ingredients
- Hydrocortisone butyrate — 1 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- The J. Molner Company LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209556
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 83148-012_407bc1b6-5851-1b87-e063-6294a90a02daSPL ID 407bc1b6-5851-1b87-e063-6294a90a02daSPL set ID 160c463e-80d2-4bca-8b7f-42279617e309RxCUI 1370763UNII 05RMF7YPWN
- 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
N483148001202followed by a unit qualifier and the quantityPackage 83148-0012-02. 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)
Hydrocortisone Butyrate Lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. Hydrocortisone Butyrate Lotion is a corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209556
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 |
|---|---|---|---|---|
| Evessehydrocortisone butyrate | Hydrocortisone butyrate 1 mg/mL | LotionTopical | Perfero Pharma, Inc. | 87143-420 |
| Hydrocortisone Butyrate | Hydrocortisone butyrate 1 mg/mL | LotionTopical | Bryant Ranch Prepack | 72162-2630 |