Prescription drug · ANDA
Pramosone NDC 83107-021
hydrocortisone acetate and pramoxine hydrochloride · Hydrocortisone acetate 25 mg/mL; Pramoxine hydrochloride 10 mg/mL · Lotion · Topical · Legacy Pharma USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83107-021-02 | 8310700210283107002102 | 59 mL in 1 BOTTLE, PLASTIC (83107-021-02)Marketed from May 27, 2025 | |
| 83107-021-04 | 8310700210483107002104 | 118 mL in 1 BOTTLE, PLASTIC (83107-021-04)Marketed from May 27, 2025 |
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)
- Pramosone
- Generic name (nonproprietary)
- hydrocortisone acetate and pramoxine hydrochloride
- Active ingredients
- Hydrocortisone acetate — 25 mg/mLPramoxine hydrochloride — 10 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Legacy Pharma USA Inc.NDC labeler code 83107
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 085979
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 83107-021_3726846b-fa95-09cb-e063-6294a90a7bf7SPL ID 3726846b-fa95-09cb-e063-6294a90a7bf7SPL set ID 4c98a01e-ff11-45eb-8732-4bd9157969e8RxCUI 1234512, 1234514UNII 3X7931PO74, 88AYB867L5
- 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
N483107002102followed by a unit qualifier and the quantityPackage 83107-0021-02. 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)
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.
About NDC 83107-021
- What is NDC 83107-021?
- 83107-021 is the product NDC for Pramosone, Hydrocortisone acetate 25 mg/mL; Pramoxine hydrochloride 10 mg/mL lotion, listed with the FDA by Legacy Pharma USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pramosone (Hydrocortisone acetate and pramoxine hydrochloride).
- What is the active ingredient?
- Hydrocortisone acetate, Pramoxine hydrochloride.
- Who is the labeler?
- Legacy Pharma USA Inc., NDC labeler code 83107. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pramosone?
- 6 other product NDCs are listed under this name. See all Pramosone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pramosone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pramosonehydrocortisone acetate and pramoxine hydrochloride | Hydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/g | OintmentTopical | Sebela Pharmaceuticals Inc. | 54766-763 | — |
| Pramosonehydrocortisone acetate and pramoxine hydrochloride | Hydrocortisone acetate 25 mg/g; Pramoxine hydrochloride 10 mg/g | OintmentTopical | Sebela Pharmaceuticals Inc. | 54766-777 | 54766-0777-04 |
| Pramosonehydrocortisone acetate and pramoxine hydrochloride | Hydrocortisone acetate 25 mg/g; Pramoxine hydrochloride 10 mg/g | OintmentTopical | Legacy Pharma USA Inc | 83107-014 | 83107-0014-01 |
| pramosonehydrocortisone acetate and pramoxine hydrochloride | Hydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/g | OintmentTopical | Legacy Pharma USA Inc. | 83107-015 | 83107-0015-01 |
| Pramosonehydrocortisone acetate and pramoxine hydrochloride | Hydrocortisone acetate 10 mg/mL; Pramoxine hydrochloride 10 mg/mL | LotionTopical | Legacy Pharma USA Inc. | 83107-022 | 83107-0022-04 |
| Pramosonehydrocortisone acetate and pramoxine hydrochloride | Hydrocortisone acetate 10 mg/mL; Pramoxine hydrochloride 10 mg/mL | LotionTopical | Sebela Pharmaceuticals Inc. | 54766-729 | 54766-0729-04 |
Other NDCs under ANDA 085979
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 |
|---|---|---|---|---|
| Analpram HChydrocortisone acetate and pramoxine hydrochloride | Hydrocortisone acetate 25 mg/g; Pramoxine hydrochloride 10 mg/g | CreamTopical | Legacy Pharma USA Inc. | 83107-019 |
| Analpram HChydrocortisone acetate and pramoxine hydrochloride | Hydrocortisone acetate 25 mg/mL; Pramoxine hydrochloride 10 mg/mL | LotionTopical | Legacy Pharma USA Inc. | 83107-020 |
| Analpram HChydrocortisone acetate and pramoxine hydrochloride | Hydrocortisone acetate 25 mg/mL; Pramoxine hydrochloride 10 mg/mL | LotionTopical | Sebela Pharmaceuticals Inc. | 54766-829 |