Nortriptyline Hydrochloride

Product NDC
50436-4022
11-digit product format
504364022
Labeler code
50436
Product ID
50436-4022_67fa633c-4919-49e1-8d0c-16f537279cc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA075520
Marketing category
ANDA
Marketing start
2000-05-08
Marketing end
0000-00-00
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct50436-4022IInactivated by FDA2026-08-03
excluded packagepackage50436-402250436-4022-2IInactivated by FDA2026-08-03

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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50436-4022-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50436-4022-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50436-4022-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50436-4022-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50436-4022-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50436-4022-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50436-4022-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50436-4022-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50436-4022-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50436-4022-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50436-4022-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50436-4022-2557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50436-4022-28af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50436-4022-2834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50436-4022-21332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50436-4022-2fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50436-4022-286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50436-4022-2bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50436-4022-28dfbde2a14a4…c9ff85d89658…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075520-001NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-05-08
A075520-002NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-05-08
A075520-003NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2000-05-08
A075520-004NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-05-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075520-001AB
A075520-002AB
A075520-003AB
A075520-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075520-001NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-05-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075520-002NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-05-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075520-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2000-05-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075520-004NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-05-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075520-001NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-05-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075520-002NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-05-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075520-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2000-05-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075520-004NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-05-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075520-001NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-05-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075520-002NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-05-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075520-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2000-05-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075520-004NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-05-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075520-001NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-05-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075520-002NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-05-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075520-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2000-05-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075520-004NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-05-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075520-001NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-05-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075520-002NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-05-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075520-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2000-05-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075520-004NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-05-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075520-001NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-05-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075520-002NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-05-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075520-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2000-05-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075520-004NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-05-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075520-001NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-05-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075520-002NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-05-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075520-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2000-05-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075520-004NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-05-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075520-001NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-05-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075520-002NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-05-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075520-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2000-05-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075520-004NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-05-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075520-001NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-05-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075520-002NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-05-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075520-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2000-05-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075520-004NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-05-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075520-001NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-05-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A075520-002NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-05-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A075520-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2000-05-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A075520-004NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-05-08d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075520-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075520-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075520-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075520-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075520-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075520-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075520-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075520-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075520-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075520-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075520-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075520-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075520-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075520-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075520-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075520-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075520-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075520-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075520-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075520-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075520-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075520-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075520-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075520-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075520-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075520-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075520-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075520-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075520-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075520-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075520-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075520-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075520-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075520-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075520-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075520-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075520-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075520-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075520-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075520-004AB1d06236e962d9…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-4022-22021-01-29C16284748780-1ba0f9c33-55f1-a910-e053-dadaa90a0b85Nortriptyline Hydrochloride Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-4022-2Nortriptyline Hydrochloride60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-4022-2EA - Each50436-4022f51fba09-221f-43af-a58f-23cde4d32b1e12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-4022NORTRIPTYLINE HYDROCHLORIDE CAPSULE [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20180419_5c736c83-45e2-4321-bf23-34e42b920706.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c282026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075520
application number: ANDA075520
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDENorthwind Health Company, LLCdae3314f-3128-787f-e053-2995a90aff192026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075520
application number: ANDA075520
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDENorthwind Health Company, LLC09a54dbd-6bde-3083-e063-6394a90a52972025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075520
application number: ANDA075520
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.51778813-0ec1-6b4f-e054-00144ff8d46c2024-07-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075520
application number: ANDA075520
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEA-S Medication Solutions53346b9c-40a1-4b5b-8df0-0b393661fb852024-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075520
application number: ANDA075520
NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEDIRECT RX45884cad-4a2d-44f4-93bd-16b130daf32d2024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075520
application number: ANDA075520
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEBryant Ranch Prepackcb4d1a69-60ae-4fdc-8af8-059959cf72652023-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075520
application number: ANDA075520
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEProficient Rx LP70921f99-1f25-4a8c-8269-6d5d26be7a632023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075520
application number: ANDA075520
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEProficient Rx LP59a65e6f-b812-4195-b85b-c412fb902c932022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075520
application number: ANDA075520
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEProficient Rx LPc5b1ef5e-9681-426a-abf6-60d9c28d92a02022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075520
application number: ANDA075520

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317136nortriptyline HCl 25 MG Oral CapsulePSN5c736c83-45e2-4321-bf23-34e42b9207062
317136nortriptyline 25 MG Oral CapsuleSCD5c736c83-45e2-4321-bf23-34e42b9207062
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY5c736c83-45e2-4321-bf23-34e42b9207062

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-4022-25043640220260 in 1 BOTTLEHistorical