Prescription drug · ANDA

Doxepin Hydrochloride NDC 83209-424

Doxepin hydrochloride 10 mg/1 · Capsule · Oral · Boswell Pharmacy Services LLC d/b/a BPS Wholesale

NDC codes

FDA NDC Directory
Product NDC (as listed)83209-424Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83209-0424Add 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
83209-424-30832090424308320904243030 CAPSULE in 1 BLISTER PACK (83209-424-30)Marketed from Sep 4, 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 Hydrochloride
Generic name (nonproprietary)
doxepin hydrochloride
Active ingredients
Doxepin hydrochloride — 10 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 83209-424_214b6c35-74ab-eea4-e063-6294a90a1b26SPL ID 214b6c35-74ab-eea4-e063-6294a90a1b26SPL set ID 214b6c28-7418-5ebd-e063-6394a90ae833RxCUI 1000048UNII 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

N483209042430 followed by a unit qualifier and the quantity

Package 83209-0424-30. 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)

INDICATIONS AND USAGE Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: Psychoneurotic patients with depression and/or anxiety. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptom…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83209-424

What is NDC 83209-424?
83209-424 is the product NDC for Doxepin Hydrochloride, Doxepin hydrochloride 10 mg/1 capsule, listed with the FDA by Boswell Pharmacy Services LLC d/b/a BPS Wholesale. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Doxepin Hydrochloride.
What is the active ingredient?
Doxepin hydrochloride.
Who is the labeler?
Boswell Pharmacy Services LLC d/b/a BPS Wholesale, NDC labeler code 83209. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Doxepin Hydrochloride?
173 other product NDCs are listed under this name. See all Doxepin Hydrochloride NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Doxepin Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Doxepin HydrochlorideDoxepin hydrochloride 50 mg/gCreamTopicalSun Pharmaceutical Industries, Inc.51672-140451672-1404-0251672-1404-09
Doxepin HydrochlorideDoxepin hydrochloride 150 mg/1CapsuleOralREMEDYREPACK INC.70518-473370518-4733-00
Doxepin hydrochlorideDoxepin hydrochloride 50 mg/1CapsuleOralCoupler LLC67046-039467046-0394-03
Doxepin hydrochlorideDoxepin hydrochloride 25 mg/1CapsuleOralCoupler LLC67046-039367046-0393-03
Doxepin HydrochlorideDoxepin hydrochloride 10 mg/1CapsuleOralSafecor Health, LLC48433-03548433-0035-20
Doxepin HydrochlorideDoxepin hydrochloride 25 mg/1CapsuleOralSafecor Health, LLC48433-03648433-0036-20
Doxepin HydrochlorideDoxepin hydrochloride 50 mg/1CapsuleOralSafecor Health, LLC48433-03748433-0037-20
Doxepin HydrochlorideDoxepin hydrochloride 100 mg/1CapsuleOralSafecor Health, LLC48433-03848433-0038-20
doxepin hydrochlorideDoxepin hydrochloride 3 mg/1TabletOralSun Pharmaceutical Industries, Inc.51672-424651672-4246-02
doxepin hydrochlorideDoxepin hydrochloride 6 mg/1TabletOralSun Pharmaceutical Industries, Inc.51672-424751672-4247-02

All 174 Doxepin Hydrochloride NDCs

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 HCLDoxepin hydrochloride 10 mg/1CapsuleOralDirect_rx72189-590
Doxepin HydrochlorideDoxepin hydrochloride 10 mg/1CapsuleOralLifestar Pharma LLC70756-424
Doxepin HydrochlorideDoxepin hydrochloride 25 mg/1CapsuleOralLifestar Pharma LLC70756-425
Doxepin HydrochlorideDoxepin hydrochloride 50 mg/1CapsuleOralLifestar Pharma LLC70756-426
Doxepin HydrochlorideDoxepin hydrochloride 75 mg/1CapsuleOralLifestar Pharma LLC70756-427
Doxepin HydrochlorideDoxepin hydrochloride 100 mg/1CapsuleOralLifestar Pharma LLC70756-428
Doxepin HydrochlorideDoxepin hydrochloride 25 mg/1CapsuleOralBryant Ranch Prepack71335-2817
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 75 mg/1CapsuleOralNorthStar RxLLC72603-393
Doxepin HydrochlorideDoxepin hydrochloride 100 mg/1CapsuleOralNorthStar RxLLC72603-394
Doxepin HydrochlorideDoxepin hydrochloride 10 mg/1CapsuleOralFirst Nation Group, LLC81469-415
Doxepin HydrochlorideDoxepin hydrochloride 25 mg/1CapsuleOralFirst Nation Group, LLC81469-416
Doxepin HydrochlorideDoxepin hydrochloride 50 mg/1CapsuleOralFirst Nation Group, LLC81469-417
Doxepin HydrochlorideDoxepin hydrochloride 75 mg/1CapsuleOralFirst Nation Group, LLC81469-418
Doxepin HydrochlorideDoxepin hydrochloride 100 mg/1CapsuleOralFirst Nation Group, LLC81469-419

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