NDC codes

FDA NDC Directory
Product NDC (as listed)72603-223Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72603-0223Add 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
72603-223-01726030223017260302230130 TABLET, FILM COATED in 1 BOTTLE (72603-223-01)Marketed from Apr 1, 2024

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
Generic name (nonproprietary)
doxepin
Active ingredients
Doxepin hydrochloride — 6 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
North Star Rx LLCNDC labeler code 72603
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202337
Marketing start
Listing expires
Identifiers
Product ID 72603-223_472f1364-17cc-0996-e063-6394a90aa786SPL ID 472f1364-17cc-0996-e063-6394a90aa786SPL set ID 12edd5c6-c863-b83a-e063-6294a90a2f36RxCUI 966787, 966793UNII 3U9A0FE9N5UPC 0372603222012, 0372603223019
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

N472603022301 followed by a unit qualifier and the quantity

Package 72603-0223-01. 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 .

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 72603-223

What is NDC 72603-223?
72603-223 is the product NDC for Doxepin, Doxepin hydrochloride 6 mg/1 tablet, film coated, listed with the FDA by North Star Rx LLC. 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?
North Star Rx LLC, NDC labeler code 72603. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DoxepinDoxepin hydrochloride 3 mg/1TabletOralNorthStar Rx LLC72603-91972603-0919-01
DoxepinDoxepin hydrochloride 6 mg/1TabletOralNorthStar Rx LLC72603-92072603-0920-01
DoxepinDoxepin hydrochloride 3 mg/1TabletOralAurobindo Pharma Limited59651-84459651-0844-30
DoxepinDoxepin hydrochloride 6 mg/1TabletOralAurobindo Pharma Limited59651-84559651-0845-30
Doxepindoxepin hydrochlorideDoxepin hydrochloride 6 mg/1TabletOralREMEDYREPACK INC.70518-432770518-4327-00
DoxepinDoxepin hydrochloride 3 mg/1TabletOralAjanta Pharma USA Inc.27241-28027241-0280-30
DoxepinDoxepin hydrochloride 6 mg/1TabletOralAjanta Pharma USA Inc.27241-28127241-0281-30
doxepinDoxepin hydrochloride 3 mg/1TabletOralZydus Lifesciences Limited70771-152870771-1528-0070771-1528-0170771-1528-03+3 more
doxepinDoxepin hydrochloride 6 mg/1TabletOralZydus Lifesciences Limited70771-152970771-1529-0070771-1529-0170771-1529-03+3 more
doxepinDoxepin hydrochloride 3 mg/1TabletOralViona Pharmaceuticals Inc72578-18172578-0181-0172578-0181-0572578-0181-06+3 more

All 24 Doxepin NDCs

Other NDCs under ANDA 202337

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

FDA NDC Directory listings under ANDA 202337
ProductStrengthForm · routeLabelerProduct NDC
DoxepinDoxepin hydrochloride 6 mg/1Tablet, Film coatedOralArchis Pharma LLC72819-162
DoxepinDoxepin hydrochloride 3 mg/1Tablet, Film coatedOralNorth Star Rx LLC72603-222
DoxepinDoxepin hydrochloride 3 mg/1Tablet, Film coatedOralMarlex Pharmaceuticals, Inc.10135-758
DoxepinDoxepin hydrochloride 6 mg/1Tablet, Film coatedOralMarlex Pharmaceuticals, Inc.10135-764
DoxepinDoxepin hydrochloride 3 mg/1Tablet, Film coatedOralArchis Pharma LLC72819-161

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in