NDC codes

FDA NDC Directory
Product NDC (as listed)27241-280Labeler and product segments. Claims need a package NDC.
Product NDC at billing width27241-0280Add 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
27241-280-30272410280302724102803030 TABLET in 1 BOTTLE (27241-280-30)Marketed from Jul 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 — 3 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Ajanta Pharma USA Inc.NDC labeler code 27241
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 218564
Marketing start
Listing expires
Identifiers
Product ID 27241-280_bfe69bed-a77f-4fa8-adef-a300fb87b7f9SPL ID bfe69bed-a77f-4fa8-adef-a300fb87b7f9SPL set ID b198ade7-fe78-437e-82b4-693dfe45ab51RxCUI 966787, 966793UNII 3U9A0FE9N5UPC 0327241281303, 0327241280306
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

N427241028030 followed by a unit qualifier and the quantity

Package 27241-0280-30. 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 27241-280

What is NDC 27241-280?
27241-280 is the product NDC for Doxepin, Doxepin hydrochloride 3 mg/1 tablet, listed with the FDA by Ajanta Pharma USA 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?
Ajanta Pharma USA Inc., NDC labeler code 27241. 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 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
doxepinDoxepin hydrochloride 6 mg/1TabletOralViona Pharmaceuticals Inc72578-18272578-0182-0172578-0182-0572578-0182-06+3 more

All 24 Doxepin NDCs

Other NDCs under ANDA 218564

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

FDA NDC Directory listings under ANDA 218564
ProductStrengthForm · routeLabelerProduct NDC
DoxepinDoxepin hydrochloride 6 mg/1TabletOralAjanta Pharma USA Inc.27241-281

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