Prescription drug · ANDA

Doxepin Hydrochloride NDC 70756-427

Doxepin hydrochloride 75 mg/1 · Capsule · Oral · Lifestar Pharma LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)70756-427Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70756-0427Add 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
70756-427-117075604271170756042711100 CAPSULE in 1 BOTTLE (70756-427-11)Marketed from Feb 10, 2022
70756-427-517075604275170756042751500 CAPSULE in 1 BOTTLE (70756-427-51)Marketed from Feb 10, 2022

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
Labeler
Lifestar Pharma LLCNDC labeler code 70756
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215710
Marketing start
Listing expires
Identifiers
Product ID 70756-427_56645f3c-452a-404f-ad51-2dab95f23e6eSPL ID 56645f3c-452a-404f-ad51-2dab95f23e6eSPL set ID fdaf3bd7-c456-40bd-8bc3-2b67eb1846c8RxCUI 1000048, 1000058, 1000070, 1000076, 1000097UNII 3U9A0FE9N5UPC 0370756425519, 0370756424512, 0370756427513
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

N470756042711 followed by a unit qualifier and the quantity

Package 70756-0427-11. 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)

About NDC 70756-427

What is NDC 70756-427?
70756-427 is the product NDC for Doxepin Hydrochloride, Doxepin hydrochloride 75 mg/1 capsule, listed with the FDA by Lifestar Pharma LLC. It has 2 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?
Lifestar Pharma LLC, NDC labeler code 70756. 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 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
Doxepin HydrochlorideDoxepin hydrochloride 10 mg/1CapsuleOralBoswell Pharmacy Services LLC d/b/a BPS Wholesale83209-424

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