Prescription drug · ANDA

Doxepin Hydrochloride NDC 62332-639

Doxepin hydrochloride 75 mg/1 · Capsule · Oral · Alembic Pharmaceuticals Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)62332-639Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62332-0639Add 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
62332-639-3162332063931100 CAPSULE in 1 BOTTLE (62332-639-31)Marketed from Apr 23, 2021
62332-639-91623320639911000 CAPSULE in 1 BOTTLE (62332-639-91)Marketed from Apr 23, 2021

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 — 75 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215076
Marketing start
Listing expires
Identifiers
Product ID 62332-639_c3977b05-a9fc-4cc4-adfc-731abe6613ddSPL ID c3977b05-a9fc-4cc4-adfc-731abe6613ddSPL set ID 4920401a-cde5-404b-82aa-c3c0e8911065RxCUI 1000048, 1000058, 1000070, 1000076, 1000097UNII 3U9A0FE9N5UPC 0362332645312
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

N462332063931 followed by a unit qualifier and the quantity

Package 62332-0639-31. 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 capsule is indicated for the treatment of major depressive disorder (MDD) in adults. Doxepin hydrochloride capsule is a tricyclic antidepressant (TCA) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215076

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

FDA NDC Directory listings under ANDA 215076
ProductStrengthForm · routeLabelerProduct NDC
Doxepin HydrochlorideDoxepin hydrochloride 25 mg/1CapsuleOralBryant Ranch Prepack71335-2557
Doxepin HydrochlorideDoxepin hydrochloride 25 mg/1CapsuleOralAdvanced Rx of Tennessee, LLC80425-0411
Doxepin HydrochlorideDoxepin hydrochloride 25 mg/1CapsuleOralBoswell Pharmacy Services LLC d/b/a BPS Wholesale83209-638
Doxepin HydrochlorideDoxepin hydrochloride 10 mg/1CapsuleOralBryant Ranch Prepack71335-2647
Doxepin HydrochlorideDoxepin hydrochloride 25 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-638
Doxepin HydrochlorideDoxepin hydrochloride 10 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-637
Doxepin HydrochlorideDoxepin hydrochloride 100 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-640
Doxepin HydrochlorideDoxepin hydrochloride 50 mg/1CapsuleOralAlembic Pharmaceuticals Inc.62332-645
Doxepin HydrochlorideDoxepin hydrochloride 50 mg/1CapsuleOralREMEDYREPACK INC.70518-4282
Doxepin HydrochlorideDoxepin hydrochloride 75 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-639
Doxepin HydrochlorideDoxepin hydrochloride 10 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-637
Doxepin HydrochlorideDoxepin hydrochloride 25 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-638
Doxepin HydrochlorideDoxepin hydrochloride 100 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-640
Doxepin HydrochlorideDoxepin hydrochloride 50 mg/1CapsuleOralAlembic Pharmaceuticals Limited46708-645
Doxepin HydrochlorideDoxepin hydrochloride 50 mg/1CapsuleOralA-S Medication Solutions50090-7184
Doxepin HydrochlorideDoxepin hydrochloride 50 mg/1CapsuleOralBryant Ranch Prepack71335-2472
Doxepin HCLDoxepin hydrochloride 10 mg/1CapsuleOralDirect_rx72189-574

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Doxepin Hydrochloride NDC 62332-639 | Med-Code