What is NDC 0228-3316?

0228-3316 is the product NDC for Doxepin, Doxepin hydrochloride 6 mg/1 tablet, film coated, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Actavis Pharma, Inc., NDC labeler code 0228. 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?

23 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Doxepin NDC 0228-3316 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0228-3316Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00228-3316Add 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
0228-3316-03	0022833160300228331603	30 TABLET, FILM COATED in 1 BOTTLE (0228-3316-03)Marketed from Jan 2, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Generic name (nonproprietary): doxepin
Active ingredients: Doxepin hydrochloride — 6 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Actavis Pharma, Inc.NDC labeler code 0228
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201951
Marketing start: Jan 2, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 0228-3316_7f10f9b0-b39a-49a0-a3ea-01ae9ac49f33SPL ID 7f10f9b0-b39a-49a0-a3ea-01ae9ac49f33SPL set ID c42333f8-1add-4f33-9458-6fe4436874a1RxCUI 966787, 966793UNII 3U9A0FE9N5UPC 0302283316039
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

N400228331603 followed by a unit qualifier and the quantity

Package 00228-3316-03. 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 Jun 1, 2023.

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 0228-3316

What is NDC 0228-3316?: 0228-3316 is the product NDC for Doxepin, Doxepin hydrochloride 6 mg/1 tablet, film coated, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Doxepin.
What is the active ingredient?: Doxepin hydrochloride.
Who is the labeler?: Actavis Pharma, Inc., NDC labeler code 0228. 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?: 23 other product NDCs are listed under this name. See all Doxepin 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 NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Doxepin	Doxepin hydrochloride 3 mg/1	TabletOral	NorthStar Rx LLC	72603-919	72603-0919-01
Doxepin	Doxepin hydrochloride 6 mg/1	TabletOral	NorthStar Rx LLC	72603-920	72603-0920-01
Doxepin	Doxepin hydrochloride 3 mg/1	TabletOral	Aurobindo Pharma Limited	59651-844	59651-0844-30
Doxepin	Doxepin hydrochloride 6 mg/1	TabletOral	Aurobindo Pharma Limited	59651-845	59651-0845-30
Doxepindoxepin hydrochloride	Doxepin hydrochloride 6 mg/1	TabletOral	REMEDYREPACK INC.	70518-4327	70518-4327-00
Doxepin	Doxepin hydrochloride 3 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-280	27241-0280-30
Doxepin	Doxepin hydrochloride 6 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-281	27241-0281-30
doxepin	Doxepin hydrochloride 3 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1528	70771-1528-0070771-1528-0170771-1528-03+3 more
doxepin	Doxepin hydrochloride 6 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1529	70771-1529-0070771-1529-0170771-1529-03+3 more
doxepin	Doxepin hydrochloride 3 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-181	72578-0181-0172578-0181-0572578-0181-06+3 more

All 24 Doxepin NDCs

Other NDCs under ANDA 201951

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

FDA NDC Directory listings under ANDA 201951
Product	Strength	Form · route	Labeler	Product NDC
Doxepin	Doxepin hydrochloride 3 mg/1	Tablet, Film coatedOral	Actavis Pharma, Inc.	0228-3315