What is NDC 70518-4297?

70518-4297 is the product NDC for Doxepin hydrochloride, Doxepin hydrochloride 6 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.

REMEDYREPACK INC., NDC labeler code 70518. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Doxepin hydrochloride NDC 70518-4297

NDC codes

FDA NDC Directory

Product NDC (as listed)70518-4297Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70518-4297Add 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 NDC	11-digit (billing)	Package	Copy
70518-4297-0	7051842970070518429700	30 POUCH in 1 BOX (70518-4297-0) / 1 TABLET in 1 POUCH (70518-4297-1)Marketed from Feb 27, 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 — 6 mg/1
Dosage form: Tablet
Route: Oral
Labeler: REMEDYREPACK INC.NDC labeler code 70518
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214823
Marketing start: Feb 27, 2025
Listing expires: Dec 31, 2027
Identifiers: Product ID 70518-4297_5a97ce00-1c5e-de76-e063-6294a90a08b5SPL ID 5a97ce00-1c5e-de76-e063-6294a90a08b5SPL set ID 7a8c56ab-5dd1-4e1a-b26a-3af45b961dd0RxCUI 966793UNII 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

N470518429700 followed by a unit qualifier and the quantity

Package 70518-4297-00. 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 Sep 3, 2026.

Indications (excerpt from the label)

Doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration. Doxepin tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. ( 1 , 14 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-4297

What is NDC 70518-4297?: 70518-4297 is the product NDC for Doxepin hydrochloride, Doxepin hydrochloride 6 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. 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?: REMEDYREPACK INC., NDC labeler code 70518. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Doxepin Hydrochloride	Doxepin hydrochloride 50 mg/g	CreamTopical	Sun Pharmaceutical Industries, Inc.	51672-1404	51672-1404-0251672-1404-09
Doxepin Hydrochloride	Doxepin hydrochloride 150 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4733	70518-4733-00
Doxepin hydrochloride	Doxepin hydrochloride 50 mg/1	CapsuleOral	Coupler LLC	67046-0394	67046-0394-03
Doxepin hydrochloride	Doxepin hydrochloride 25 mg/1	CapsuleOral	Coupler LLC	67046-0393	67046-0393-03
Doxepin Hydrochloride	Doxepin hydrochloride 10 mg/1	CapsuleOral	Safecor Health, LLC	48433-035	48433-0035-20
Doxepin Hydrochloride	Doxepin hydrochloride 25 mg/1	CapsuleOral	Safecor Health, LLC	48433-036	48433-0036-20
Doxepin Hydrochloride	Doxepin hydrochloride 50 mg/1	CapsuleOral	Safecor Health, LLC	48433-037	48433-0037-20
Doxepin Hydrochloride	Doxepin hydrochloride 100 mg/1	CapsuleOral	Safecor Health, LLC	48433-038	48433-0038-20
doxepin hydrochloride	Doxepin hydrochloride 3 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	51672-4246	51672-4246-02
doxepin hydrochloride	Doxepin hydrochloride 6 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	51672-4247	51672-4247-02

All 174 Doxepin hydrochloride NDCs

Other NDCs under ANDA 214823

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

FDA NDC Directory listings under ANDA 214823
Product	Strength	Form · route	Labeler	Product NDC
Doxepin hydrochloride	Doxepin hydrochloride 3 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-811
Doxepin hydrochloride	Doxepin hydrochloride 6 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-812
Doxepin hydrochloride	Doxepin hydrochloride 3 mg/1	TabletOral	Novadoz Pharmaceuticals LLC	72205-052
Doxepin hydrochloride	Doxepin hydrochloride 6 mg/1	TabletOral	Novadoz Pharmaceuticals LLC	72205-053