Prescription drug · ANDA

Doxepin Hydrochloride NDC 71335-2804

Doxepin hydrochloride 50 mg/1 · Capsule · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2804Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2804Add 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
71335-2804-1713352804017133528040160 CAPSULE in 1 BOTTLE, PLASTIC (71335-2804-1)Marketed from Oct 13, 2025
71335-2804-2713352804027133528040230 CAPSULE in 1 BOTTLE, PLASTIC (71335-2804-2)Marketed from Oct 13, 2025
71335-2804-3713352804037133528040390 CAPSULE in 1 BOTTLE, PLASTIC (71335-2804-3)Marketed from Oct 13, 2025
71335-2804-47133528040471335280404120 CAPSULE in 1 BOTTLE, PLASTIC (71335-2804-4)Marketed from Oct 13, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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/1
Dosage form
Capsule
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215113
Marketing start
Listing expires
Identifiers
Product ID 71335-2804_a1efdaac-6a7a-4f99-ba57-6dee8278bc54SPL ID a1efdaac-6a7a-4f99-ba57-6dee8278bc54SPL set ID 94ee3c14-0ccc-4329-b012-63679a699a67RxCUI 1000076UNII 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

N471335280401 followed by a unit qualifier and the quantity

Package 71335-2804-01. 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 ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2804

What is NDC 71335-2804?
71335-2804 is the product NDC for Doxepin Hydrochloride, Doxepin hydrochloride 50 mg/1 capsule, listed with the FDA by Bryant Ranch Prepack. It has 4 package NDCs, 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 215113

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

FDA NDC Directory listings under ANDA 215113
ProductStrengthForm · routeLabelerProduct NDC
Doxepin HCLDoxepin hydrochloride 10 mg/1CapsuleOralDirect_Rx72189-633
Doxepin HydrochlorideDoxepin hydrochloride 50 mg/1CapsuleOralA-S Medication Solutions50090-7819
Doxepin HydrochlorideDoxepin hydrochloride 100 mg/1CapsuleOralREMEDYREPACK INC.70518-4179
Doxepin HydrochlorideDoxepin hydrochloride 75 mg/1CapsuleOralREMEDYREPACK INC.70518-4222
Doxepin HydrochlorideDoxepin hydrochloride 50 mg/1CapsuleOralREMEDYREPACK INC.70518-4231
Doxepin HydrochlorideDoxepin hydrochloride 25 mg/1CapsuleOralREMEDYREPACK INC.70518-4238
Doxepin HydrochlorideDoxepin hydrochloride 10 mg/1CapsuleOralREMEDYREPACK INC.70518-4252
Doxepin HydrochlorideDoxepin hydrochloride 25 mg/1CapsuleOralBryant Ranch Prepack71335-2418
Doxepin HydrochlorideDoxepin hydrochloride 10 mg/1CapsuleOralBryant Ranch Prepack71335-2452
Doxepin HydrochlorideDoxepin hydrochloride 10 mg/1CapsuleOralNovadoz Pharmaceuticals LLC72205-088
Doxepin HydrochlorideDoxepin hydrochloride 25 mg/1CapsuleOralNovadoz Pharmaceuticals LLC72205-089
Doxepin HydrochlorideDoxepin hydrochloride 50 mg/1CapsuleOralNovadoz Pharmaceuticals LLC72205-090
Doxepin HydrochlorideDoxepin hydrochloride 75 mg/1CapsuleOralNovadoz Pharmaceuticals LLC72205-091
Doxepin HydrochlorideDoxepin hydrochloride 100 mg/1CapsuleOralNovadoz Pharmaceuticals LLC72205-092
Doxepin HydrochlorideDoxepin hydrochloride 10 mg/1CapsuleOralProficient Rx LP82804-305

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