Prescription drug · ANDA
Texacort (Hydrocortisone) NDC 0178-0455
Hydrocortisone 25 mg/mL · Solution · Topical · Mission Pharmacal Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0178-0455-01 | 00178045501 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0178-0455-01) / 30 mL in 1 BOTTLE, WITH APPLICATORMarketed from Dec 15, 2011 |
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)
- Texacort
- Generic name (nonproprietary)
- hydrocortisone
- Active ingredients
- Hydrocortisone — 25 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Mission Pharmacal CompanyNDC labeler code 0178
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 081271
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0178-0455_47e75db6-40d5-7014-e063-6294a90afcfbSPL ID 47e75db6-40d5-7014-e063-6294a90afcfbSPL set ID 25279d46-6bad-471f-8bd6-736d53cfd942RxCUI 197786, 206336UNII WI4X0X7BPJ
- 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
N400178045501followed by a unit qualifier and the quantityPackage 00178-0455-01. 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 Texacort Topical Solution 2.5% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroids-responsive dermatoses.
Excerpt only. Read the full label for complete information.
About NDC 0178-0455
- What is NDC 0178-0455?
- 0178-0455 is the product NDC for Texacort (hydrocortisone), Hydrocortisone 25 mg/mL solution, listed with the FDA by Mission Pharmacal Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Texacort (Hydrocortisone).
- What is the active ingredient?
- Hydrocortisone.
- Who is the labeler?
- Mission Pharmacal Company, NDC labeler code 0178. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Texacort?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 081271
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 |
|---|---|---|---|---|
| Hydrocortisone | Hydrocortisone 25 mg/mL | SolutionTopical | Trifluent Pharma LLC | 73352-455 |