Prescription drug · ANDA

Doxepin Hydrochloride NDC 81469-419

Doxepin hydrochloride 100 mg/1 · Capsule · Oral · First Nation Group, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)81469-419Labeler and product segments. Claims need a package NDC.
Product NDC at billing width81469-0419Add 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
81469-419-0181469041901100 CAPSULE in 1 BOTTLE (81469-419-01)Marketed from Jan 11, 2023
81469-419-0581469041905500 CAPSULE in 1 BOTTLE (81469-419-05)Marketed from Jan 11, 2023

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 Hydrochloride
Generic name (nonproprietary)
doxepin hydrochloride
Active ingredients
Doxepin hydrochloride — 100 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215710
Marketing start
Listing expires
Identifiers
Product ID 81469-419_55da757c-42d2-4963-b06f-def9f18a423fSPL ID 55da757c-42d2-4963-b06f-def9f18a423fSPL set ID 3d4f84a4-07a1-4d0e-85f5-dcd43b236a42RxCUI 1000048, 1000058, 1000070, 1000076, 1000097UNII 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N481469041901 followed by a unit qualifier and the quantity

Package 81469-0419-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Doxepin hydrochloride capsules are indicated for the treatment of major depressive disorder (MDD) in adults. Doxepin hydrochloride capsules are a tricyclic antidepressant (TCA) indicated for the treatment of major depressive disorder (MDD) in adults.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215710

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

FDA NDC Directory listings under ANDA 215710
ProductStrengthForm · routeLabelerProduct NDC
Doxepin HydrochlorideDoxepin hydrochloride 50 mg/1CapsuleOralFirst Nation Group, LLC81469-417
Doxepin HydrochlorideDoxepin hydrochloride 75 mg/1CapsuleOralFirst Nation Group, LLC81469-418
Doxepin HydrochlorideDoxepin hydrochloride 10 mg/1CapsuleOralBoswell Pharmacy Services LLC d/b/a BPS Wholesale83209-424
Doxepin HydrochlorideDoxepin hydrochloride 25 mg/1CapsuleOralFirst Nation Group, LLC81469-416
Doxepin HydrochlorideDoxepin hydrochloride 10 mg/1CapsuleOralFirst Nation Group, LLC81469-415
Doxepin HydrochlorideDoxepin hydrochloride 75 mg/1CapsuleOralNorthStar RxLLC72603-393
Doxepin HydrochlorideDoxepin hydrochloride 10 mg/1CapsuleOralNorthStar RxLLC72603-390
Doxepin HydrochlorideDoxepin hydrochloride 25 mg/1CapsuleOralNorthStar RxLLC72603-391
Doxepin HydrochlorideDoxepin hydrochloride 50 mg/1CapsuleOralNorthStar RxLLC72603-392
Doxepin HydrochlorideDoxepin hydrochloride 100 mg/1CapsuleOralNorthStar RxLLC72603-394
Doxepin HydrochlorideDoxepin hydrochloride 50 mg/1CapsuleOralLifestar Pharma LLC70756-426
Doxepin HydrochlorideDoxepin hydrochloride 10 mg/1CapsuleOralLifestar Pharma LLC70756-424
Doxepin HydrochlorideDoxepin hydrochloride 25 mg/1CapsuleOralLifestar Pharma LLC70756-425
Doxepin HydrochlorideDoxepin hydrochloride 75 mg/1CapsuleOralLifestar Pharma LLC70756-427
Doxepin HydrochlorideDoxepin hydrochloride 100 mg/1CapsuleOralLifestar Pharma LLC70756-428
Doxepin HCLDoxepin hydrochloride 10 mg/1CapsuleOralDirect_rx72189-590
Doxepin HydrochlorideDoxepin hydrochloride 25 mg/1CapsuleOralBryant Ranch Prepack71335-2817

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Doxepin Hydrochloride NDC 81469-419 | Med-Code