Prescription drug · ANDA
Hydrocortisone Valerate NDC 0713-0560
Hydrocortisone valerate 2 mg/g · Ointment · Topical · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0560-15 | 0071305601500713056015 | 1 TUBE in 1 CARTON (0713-0560-15) / 15 g in 1 TUBEMarketed from May 3, 2021 | |
| 0713-0560-37 | 0071305603700713056037 | 1 TUBE in 1 CARTON (0713-0560-37) / 45 g in 1 TUBEMarketed from May 3, 2021 | |
| 0713-0560-60 | 0071305606000713056060 | 1 TUBE in 1 CARTON (0713-0560-60) / 60 g in 1 TUBEMarketed from May 3, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Valerate
- Generic name (nonproprietary)
- hydrocortisone valerate
- Active ingredients
- Hydrocortisone valerate — 2 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Cosette Pharmaceuticals, Inc.NDC labeler code 0713
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211764
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0713-0560_0b46d11e-449c-315b-e063-6294a90a6e2aSPL ID 0b46d11e-449c-315b-e063-6294a90a6e2aSPL set ID 1cb06573-1ac8-4dfe-8123-00bbd20a1650RxCUI 1370750UNII 68717P8FUZUPC 0307130560603
- 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
N400713056015followed by a unit qualifier and the quantityPackage 00713-0560-15. 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 valerate ointment USP, 0.2% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients.
Excerpt only. Read the full label for complete information.
About NDC 0713-0560
- What is NDC 0713-0560?
- 0713-0560 is the product NDC for Hydrocortisone Valerate, Hydrocortisone valerate 2 mg/g ointment, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydrocortisone Valerate.
- What is the active ingredient?
- Hydrocortisone valerate.
- Who is the labeler?
- Cosette Pharmaceuticals, Inc., NDC labeler code 0713. 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 Valerate?
- 5 other product NDCs are listed under this name. See all Hydrocortisone Valerate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydrocortisone Valerate 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 Valerate | Hydrocortisone valerate 2 mg/g | CreamTopical | Cosette Pharmaceuticals, Inc. | 0713-0720 | 00713-0720-1500713-0720-3700713-0720-60 |
| Hydrocortisone Valerate | Hydrocortisone valerate 2 mg/g | CreamTopical | Lupin Pharmaceuticals, Inc. | 68180-954 | 68180-0954-0168180-0954-0268180-0954-03 |
| Hydrocortisone Valerate | Hydrocortisone valerate 2 mg/g | OintmentTopical | Glenmark Pharmaceuticals Inc., USA | 68462-836 | 68462-0836-1768462-0836-4768462-0836-65 |
| Hydrocortisone Valerate | Hydrocortisone valerate 2 mg/g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-1290 | 51672-1290-0151672-1290-0351672-1290-06 |
| Hydrocortisone Valerate | Hydrocortisone valerate 2 mg/g | OintmentTopical | Sun Pharmaceutical Industries, Inc. | 51672-1292 | 51672-1292-0151672-1292-0351672-1292-06 |