Prescription drug · ANDA
Hydrocortisone Butyrate NDC 51672-4074
Hydrocortisone butyrate 1 mg/g · Cream · Topical · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-4074-1 | 5167240740151672407401 | 1 TUBE in 1 CARTON (51672-4074-1) / 15 g in 1 TUBEMarketed from Aug 4, 2005 | |
| 51672-4074-2 | 5167240740251672407402 | 1 TUBE in 1 CARTON (51672-4074-2) / 30 g in 1 TUBEMarketed from Aug 4, 2005 | |
| 51672-4074-5 | 5167240740551672407405 | 5 g in 1 TUBE (51672-4074-5)Marketed from Aug 4, 2005 | |
| 51672-4074-6 | 5167240740651672407406 | 1 TUBE in 1 CARTON (51672-4074-6) / 45 g in 1 TUBEMarketed from Aug 4, 2005 | |
| 51672-4074-7 | 5167240740751672407407 | 1 TUBE in 1 CARTON (51672-4074-7) / 10 g in 1 TUBEMarketed from Aug 4, 2005 |
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)
- Hydrocortisone Butyrate
- Generic name (nonproprietary)
- hydrocortisone butyrate
- Active ingredients
- Hydrocortisone butyrate — 1 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 51672
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076654
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 51672-4074_569a2af8-f939-4967-e063-6394a90a7726SPL ID 569a2af8-f939-4967-e063-6394a90a7726SPL set ID 51176835-598d-4da7-8a00-6bd36f52aa82RxCUI 1370758, 1370767, 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
N451672407401followed by a unit qualifier and the quantityPackage 51672-4074-01. 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)
INDICATIONS AND USAGE Hydrocortisone Butyrate Ointment, 0.1% and Hydrocortisone Butyrate Cream USP, 0.1% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Hydrocortisone Butyrate Topical Solution, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of seborrheic dermatitis.
Excerpt only. Read the full label for complete information.
About NDC 51672-4074
- What is NDC 51672-4074?
- 51672-4074 is the product NDC for Hydrocortisone Butyrate, Hydrocortisone butyrate 1 mg/g cream, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 5 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?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 51672. 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 | CreamTopical | Oceanside Pharmaceuticals | 68682-384 | 68682-0384-4568682-0384-60 |
| Hydrocortisone Butyrate | Hydrocortisone butyrate 1 mg/g | OintmentTopical | Oceanside Pharmaceuticals | 68682-271 | 68682-0271-1568682-0271-45 |
| 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 |