Prescription drug · ANDA

doxepin NDC 72578-181

Doxepin hydrochloride 3 mg/1 · Tablet · Oral · Viona Pharmaceuticals Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)72578-181Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72578-0181Add 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
72578-181-0172578018101100 TABLET in 1 BOTTLE (72578-181-01)Marketed from Jun 30, 2024
72578-181-0572578018105500 TABLET in 1 BOTTLE (72578-181-05)Marketed from Jun 30, 2024
72578-181-067257801810630 TABLET in 1 BOTTLE (72578-181-06)Marketed from Jun 30, 2024
72578-181-10725780181101000 TABLET in 1 BOTTLE (72578-181-10)Marketed from Jun 30, 2024
72578-181-167257801811690 TABLET in 1 BOTTLE (72578-181-16)Marketed from Jun 30, 2024
72578-181-777257801817710 BLISTER PACK in 1 CARTON (72578-181-77) / 10 TABLET in 1 BLISTER PACKMarketed from Jun 30, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
Generic name (nonproprietary)
doxepin
Active ingredients
Doxepin hydrochloride — 3 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202761
Marketing start
Listing expires
Identifiers
Product ID 72578-181_d569143c-aee2-4e03-988d-1ef10950e7ceSPL ID d569143c-aee2-4e03-988d-1ef10950e7ceSPL set ID 3377541d-db46-4fd9-9a4b-faa5f6108e67RxCUI 966787, 966793UNII 3U9A0FE9N5UPC 0372578181062, 0372578182069
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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N472578018101 followed by a unit qualifier and the quantity

Package 72578-0181-01. 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)

Doxepin tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. ( 1 , 14 ) Doxepin Tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202761

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 202761
ProductStrengthForm · routeLabelerProduct NDC
doxepinDoxepin hydrochloride 3 mg/1TabletOralZydus Lifesciences Limited70771-1528
doxepinDoxepin hydrochloride 6 mg/1TabletOralZydus Lifesciences Limited70771-1529
doxepinDoxepin hydrochloride 6 mg/1TabletOralViona Pharmaceuticals Inc72578-182

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doxepin NDC 72578-181 | Med-Code