Prescription drug · NDA AUTHORIZED GENERIC
Hydrocortisone Butyrate NDC 68682-384
Hydrocortisone butyrate 1 mg/g · Cream · Topical · Oceanside Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68682-384-45 | 6868203844568682038445 | 1 TUBE in 1 CARTON (68682-384-45) / 45 g in 1 TUBEMarketed from Jul 3, 2013 | |
| 68682-384-60 | 6868203846068682038460 | 1 TUBE in 1 CARTON (68682-384-60) / 60 g in 1 TUBEMarketed from Jul 3, 2013 |
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/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Oceanside PharmaceuticalsNDC labeler code 68682
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020769
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68682-384_36d82d8e-8303-bf39-e063-6394a90a2fabSPL ID 36d82d8e-8303-bf39-e063-6394a90a2fabSPL set ID ddf699f4-1ae0-48c3-8d2a-56aa1a2c5bc1RxCUI 1370770UNII 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
N468682038445followed by a unit qualifier and the quantityPackage 68682-0384-45. 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 Cream (lipid), 0.1% is indicated for: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults. The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older. Hydrocortisone Butyrate Cream (lipid), 0.1% is a corticosteroid indicated for: Relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in adults. ( 1 ) The topical treatment of mild to moderate atopic dermatitis in pediatric patients 3 months of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 68682-384
- What is NDC 68682-384?
- 68682-384 is the product NDC for Hydrocortisone Butyrate, Hydrocortisone butyrate 1 mg/g cream, listed with the FDA by Oceanside Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydrocortisone Butyrate.
- What is the active ingredient?
- Hydrocortisone butyrate.
- Who is the labeler?
- Oceanside Pharmaceuticals, NDC labeler code 68682. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hydrocortisone Butyrate?
- 7 other product NDCs are listed under this name. See all Hydrocortisone Butyrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydrocortisone Butyrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hydrocortisone Butyrate | Hydrocortisone butyrate 1 mg/mL | LotionTopical | Bryant Ranch Prepack | 72162-2630 | 72162-2630-0272162-2630-04 |
| Hydrocortisone Butyrate | Hydrocortisone butyrate 1 mg/mL | LotionTopical | The J. Molner Company LLC | 83148-012 | 83148-0012-0283148-0012-04 |
| Hydrocortisone Butyrate | Hydrocortisone butyrate 1 mg/mL | LotionTopical | Lupin Pharmaceuticals, Inc. | 68180-951 | 68180-0951-0168180-0951-02 |
| Hydrocortisone Butyrate | Hydrocortisone butyrate 1 mg/g | OintmentTopical | Oceanside Pharmaceuticals | 68682-271 | 68682-0271-1568682-0271-45 |
| Hydrocortisone Butyrate | Hydrocortisone butyrate 1 mg/g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-4074 | 51672-4074-0151672-4074-0251672-4074-05+2 more |
| Hydrocortisone Butyrate | Hydrocortisone butyrate 1 mg/g | OintmentTopical | Sun Pharmaceutical Industries, Inc. | 51672-4083 | 51672-4083-0151672-4083-0251672-4083-05+2 more |
| Hydrocortisone Butyrate | Hydrocortisone butyrate 1 mg/mL | SolutionTopical | Sun Pharmaceutical Industries, Inc. | 51672-4061 | 51672-4061-0251672-4061-04 |