NDC codes

FDA NDC Directory
Product NDC (as listed)0178-0455Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00178-0455Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0178-0455-01001780455011 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

N400178045501 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under ANDA 081271
ProductStrengthForm · routeLabelerProduct NDC
HydrocortisoneHydrocortisone 25 mg/mLSolutionTopicalTrifluent Pharma LLC73352-455

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