What is NDC 46708-640?

46708-640 is the product NDC for Doxepin Hydrochloride, Doxepin hydrochloride 100 mg/1 capsule, listed with the FDA by Alembic Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 46708-640

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-640Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0640Add 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
46708-640-31	4670806403146708064031	100 CAPSULE in 1 BOTTLE (46708-640-31)Marketed from Apr 23, 2021
46708-640-91	4670806409146708064091	1000 CAPSULE in 1 BOTTLE (46708-640-91)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 — 100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215076
Marketing start: Apr 23, 2021
Listing expires: Dec 31, 2027
Identifiers: Product ID 46708-640_5c5c56f2-76f7-41b1-8eb5-40dc4cd4ac6aSPL ID 5c5c56f2-76f7-41b1-8eb5-40dc4cd4ac6aSPL set ID 842b595b-dc54-4898-a178-1d2241cc065fRxCUI 1000048, 1000058, 1000070, 1000076, 1000097UNII 3U9A0FE9N5UPC 0346708638313, 0346708639310
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

N446708064031 followed by a unit qualifier and the quantity

Package 46708-0640-31. 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 Jan 27, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Doxepin hydrochloride capsules 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 symptoms and…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-640

What is NDC 46708-640?: 46708-640 is the product NDC for Doxepin Hydrochloride, Doxepin hydrochloride 100 mg/1 capsule, listed with the FDA by Alembic Pharmaceuticals Limited. 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 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
Product	Strength	Form · route	Labeler	Product NDC
Doxepin HCL	Doxepin hydrochloride 10 mg/1	CapsuleOral	Direct_rx	72189-574
Doxepin Hydrochloride	Doxepin hydrochloride 10 mg/1	CapsuleOral	Alembic Pharmaceuticals Limited	46708-637
Doxepin Hydrochloride	Doxepin hydrochloride 25 mg/1	CapsuleOral	Alembic Pharmaceuticals Limited	46708-638
Doxepin Hydrochloride	Doxepin hydrochloride 75 mg/1	CapsuleOral	Alembic Pharmaceuticals Limited	46708-639
Doxepin Hydrochloride	Doxepin hydrochloride 50 mg/1	CapsuleOral	Alembic Pharmaceuticals Limited	46708-645
Doxepin Hydrochloride	Doxepin hydrochloride 50 mg/1	CapsuleOral	A-S Medication Solutions	50090-7184
Doxepin Hydrochloride	Doxepin hydrochloride 10 mg/1	CapsuleOral	Alembic Pharmaceuticals Inc.	62332-637
Doxepin Hydrochloride	Doxepin hydrochloride 25 mg/1	CapsuleOral	Alembic Pharmaceuticals Inc.	62332-638
Doxepin Hydrochloride	Doxepin hydrochloride 75 mg/1	CapsuleOral	Alembic Pharmaceuticals Inc.	62332-639
Doxepin Hydrochloride	Doxepin hydrochloride 100 mg/1	CapsuleOral	Alembic Pharmaceuticals Inc.	62332-640
Doxepin Hydrochloride	Doxepin hydrochloride 50 mg/1	CapsuleOral	Alembic Pharmaceuticals Inc.	62332-645
Doxepin Hydrochloride	Doxepin hydrochloride 50 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4282
Doxepin Hydrochloride	Doxepin hydrochloride 50 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2472
Doxepin Hydrochloride	Doxepin hydrochloride 25 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2557
Doxepin Hydrochloride	Doxepin hydrochloride 10 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2647
Doxepin Hydrochloride	Doxepin hydrochloride 25 mg/1	CapsuleOral	Advanced Rx of Tennessee, LLC	80425-0411
Doxepin Hydrochloride	Doxepin hydrochloride 25 mg/1	CapsuleOral	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	83209-638