Prescription drug · NDA AUTHORIZED GENERIC
Doxepin Hydrochloride NDC 0378-8117
Doxepin hydrochloride 50 mg/g · Cream · Topical · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-8117-45 | 00378811745 | 1 TUBE in 1 CARTON (0378-8117-45) / 45 g in 1 TUBEMarketed from Jan 4, 2019 |
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)
- Doxepin Hydrochloride
- Generic name (nonproprietary)
- doxepin hydrochloride
- Active ingredients
- Doxepin hydrochloride — 50 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020126
- Marketing start
- Listing expires
- Identifiers
- Product ID 0378-8117_b4771ea7-c19b-4182-bb23-c1473ab583faSPL ID b4771ea7-c19b-4182-bb23-c1473ab583faSPL set ID b4771ea7-c19b-4182-bb23-c1473ab583faRxCUI 1000091UNII 3U9A0FE9N5
- Pharmacologic class
- Tricyclic Antidepressant
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
N400378811745followed by a unit qualifier and the quantityPackage 00378-8117-45. 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)
INDICATIONS AND USAGE Doxepin Hydrochloride Cream, 5% is indicated for the short-term (up to 8 days) management of moderate pruritus in adult patients with atopic dermatitis or lichen simplex chronicus. (See DOSAGE AND ADMINISTRATION .)
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020126
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.