FDA.reportPublic FDA data

Doxepin

Product NDC
27241-280
11-digit product format
272410280
Labeler code
27241
Product ID
27241-280_7b7e70e8-815c-4ba4-9a9a-e7b5627ed6ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxepin
Dosage form
TABLET
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA218564
Marketing category
ANDA
Marketing start
2024-07-01
Substance
DOXEPIN HYDROCHLORIDE
Active strength
3 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxepin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXEPIN HYDROCHLORIDE3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3U9A0FE9N5
Rxcui966787, 966793

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f6fcd62d-384f-5faa-05d7-c5d5903c6c43Product name420250515
3d5463a5-d368-9c2b-b40c-0f2b688e406eProduct name920240805
750bc85a-c69c-4145-a865-3f1124677d16Product name320240321
eda77195-5c17-5c7f-a6a7-8c80d2f8ae5fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-280-30Doxepin30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-280-30EA - Each27241-2805655d5f4-0d41-48d3-814f-aaaaa30c093c12025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-280DOXEPIN TABLET [AJANTA PHARMA USA INC.]2Current NDC, 1 package rows20240706_b198ade7-fe78-437e-82b4-693dfe45ab51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966787doxepin 3 MG Oral TabletPSNb198ade7-fe78-437e-82b4-693dfe45ab512
966793doxepin 6 MG Oral TabletPSNb198ade7-fe78-437e-82b4-693dfe45ab512
966787doxepin 3 MG Oral TabletSCDb198ade7-fe78-437e-82b4-693dfe45ab512
966793doxepin 6 MG Oral TabletSCDb198ade7-fe78-437e-82b4-693dfe45ab512
966787doxepin 3 MG (as doxepin hydrochloride 3.39 MG) Oral TabletSYb198ade7-fe78-437e-82b4-693dfe45ab512
966793doxepin 6 MG (as doxepin hydrochloride 6.78 MG) Oral TabletSYb198ade7-fe78-437e-82b4-693dfe45ab512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
27241-280-302724102803030 TABLET in 1 BOTTLE (27241-280-30) 30 tablet2024-07-01NoNoCurrent