NORTRIPTYLINE HYDROCHLORIDE

Product NDC
61919-238
11-digit product format
619190238
Labeler code
61919
Product ID
61919-238_35e17692-7874-269a-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NORTRIPTYLINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA074132
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-238UExcluded because listing certification expired2026-08-17
excluded packagepackage61919-23861919-238-60UExcluded because listing certification expired2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductUExcluded because listing certification expiredd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-238-60UExcluded because listing certification expiredd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductUExcluded because listing certification expiredf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-238-60UExcluded because listing certification expiredf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductUExcluded because listing certification expired2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-238-60UExcluded because listing certification expired2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductUExcluded because listing certification expireda1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-238-60UExcluded because listing certification expireda1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductUExcluded because listing certification expiredcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-238-60UExcluded because listing certification expiredcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductUExcluded because listing certification expiredcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-238-60UExcluded because listing certification expiredcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-238-60UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-238-60UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-238-60UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductUExcluded because listing certification expiredad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-238-60UExcluded because listing certification expiredad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductUExcluded because listing certification expired367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-238-60UExcluded because listing certification expired367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductUExcluded because listing certification expired557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-238-60UExcluded because listing certification expired557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductUExcluded because listing certification expired8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-238-60UExcluded because listing certification expired8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductUExcluded because listing certification expired834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-238-60UExcluded because listing certification expired834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductUExcluded because listing certification expired1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-238-60UExcluded because listing certification expired1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductUExcluded because listing certification expiredfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61919-238-60UExcluded because listing certification expiredfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductUExcluded because listing certification expired86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61919-238-60UExcluded because listing certification expired86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductUExcluded because listing certification expiredbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61919-238-60UExcluded because listing certification expiredbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductUExcluded because listing certification expired8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage61919-238-60UExcluded because listing certification expired8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductEExcluded after deficient or non-compliant submission was not correctede2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage61919-238-60EExcluded after deficient or non-compliant submission was not correctede2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductEExcluded after deficient or non-compliant submission was not corrected9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage61919-238-60EExcluded after deficient or non-compliant submission was not corrected9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61919-238-60EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074132-001NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-27
A074132-002NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-27
A074132-003NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-27
A074132-004NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRS1995-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A074132-001AB
A074132-002AB
A074132-003AB
A074132-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRS1995-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRS1995-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRS1995-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRS1995-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRS1995-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRS1995-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRS1995-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1995-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1995-03-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1995-03-27d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074132-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074132-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074132-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074132-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074132-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074132-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074132-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074132-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074132-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074132-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074132-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074132-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074132-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074132-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074132-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074132-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074132-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074132-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074132-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074132-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074132-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074132-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074132-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074132-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074132-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074132-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074132-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074132-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074132-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074132-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074132-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074132-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074132-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074132-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074132-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074132-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074132-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074132-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074132-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074132-004AB1d8e5a09893c0…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
de76de11-1019-6138-2d8a-16fa566ae22aProduct name220241009
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-238-60NORTRIPTYLINE HYDROCHLORIDE60 in 1 BOTTLECAPSULE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-238-60EA - Each61919-238957f9a70-d163-4c53-a079-dbb42b87e4cd12016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NORTRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT00FN6IH15DNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
NORTRIPTYLINEACTIVE MOIETYBL03SY4LXBNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ONORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
SHELLACINACTIVE INGREDIENT46N107B71ONORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-238NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]5Legacy NDC, 1 package rows20161115_9386627f-3522-425b-b0b0-f4d9d30ad98e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.dd1f4d6f-14cc-44c0-b9d3-bb3d17b557fa2026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.522d0cd8-d84d-4961-a525-4527fce44c3c2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEA-S Medication Solutionsa2cf7783-7019-49ea-ab55-796674d945462026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack8eef261f-5c78-a88f-37c4-46e6b0e0f0ee2026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDECoupler LLC4c21abdb-f3e9-9037-e063-6294a90af4b42026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEDirect Rx017f7717-e160-4142-9a5a-1a2bd97767072026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEAmerican Health Packagingd111c36d-98ed-4f0d-97ea-86fe9048deee2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEA-S Medication Solutions686d15d0-6434-42ec-8c78-f45d617d294c2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack962f3f54-0556-4509-a231-ca62cb01bec82025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack43a81887-42b8-43b5-b58a-3f3df2e9949b2025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.b58d473a-b19f-4d2a-b1ae-dd398d7a29e12025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEProficient Rx LPe047f990-c374-4f8f-8583-c615f92545e22024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEProficient Rx LP2f9fc7a0-163a-4a05-84a7-7999a41ecb1f2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEProficient Rx LPb387ba49-fd3f-4488-86e8-9b81e85ab2322024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCf1868790-c70b-4979-974d-3ce0ffe99e362024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEProficient Rx LP30263e15-de21-4db4-aceb-59d619909e822023-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198046nortriptyline HCl 50 MG Oral CapsulePSN9386627f-3522-425b-b0b0-f4d9d30ad98e5
198046nortriptyline 50 MG Oral CapsuleSCD9386627f-3522-425b-b0b0-f4d9d30ad98e5
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSY9386627f-3522-425b-b0b0-f4d9d30ad98e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-238-606191902386060 in 1 BOTTLEHistorical