Nortriptyline HCL

Product NDC
61919-742
11-digit product format
619190742
Labeler code
61919
Product ID
61919-742_83e59e10-986f-e5c2-e053-2a91aa0af25e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA073556
Marketing category
ANDA
Marketing start
2019-01-23
Marketing end
0000-00-00
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
50 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 productproduct61919-742IInactivated by FDA2026-08-03
excluded packagepackage61919-74261919-742-60IInactivated 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 · 30 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 packagepackage61919-742-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-742-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-742-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-742-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-742-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-742-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-742-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-742-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-742-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-742-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-742-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-742-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-742-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-742-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-742-601332a3947898…d4bfe170f9cd…

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
A073556-001NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1992-03-30
A073556-002NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1992-03-30
A073556-003NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1992-03-30
A073556-004NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1992-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A073556-001AB
A073556-002AB
A073556-003AB
A073556-004AB

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 UTC2026-02A073556-001NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1992-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073556-002NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1992-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073556-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1992-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073556-004NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1992-03-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073556-001NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1992-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073556-002NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1992-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073556-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1992-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073556-004NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1992-03-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A073556-001NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1992-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073556-002NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1992-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073556-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1992-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073556-004NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1992-03-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073556-001NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1992-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073556-002NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1992-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073556-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1992-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073556-004NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1992-03-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073556-001NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1992-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073556-002NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1992-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073556-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1992-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073556-004NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1992-03-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073556-001NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1992-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073556-002NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1992-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073556-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1992-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073556-004NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1992-03-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073556-001NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1992-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073556-002NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1992-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073556-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1992-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073556-004NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1992-03-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073556-001NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1992-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073556-002NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1992-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073556-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1992-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073556-004NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1992-03-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073556-001NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1992-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073556-002NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1992-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073556-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1992-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073556-004NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1992-03-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073556-001NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1992-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A073556-002NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1992-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A073556-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1992-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A073556-004NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1992-03-30d06236e962d9…

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 UTC2026-02A073556-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073556-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073556-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073556-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073556-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073556-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073556-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073556-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A073556-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073556-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073556-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073556-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073556-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073556-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073556-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073556-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073556-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073556-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073556-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073556-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073556-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073556-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073556-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073556-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073556-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073556-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073556-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073556-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073556-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073556-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073556-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073556-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073556-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073556-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073556-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073556-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073556-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A073556-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A073556-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A073556-004AB1d06236e962d9…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
de76de11-1019-6138-2d8a-16fa566ae22aProduct name220241009
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-742-602025-01-30C16284748780-11030e365-5f51-111a-e063-dadaa90a10e2Nortriptyline HCL
61919-742-602024-01-30C16284748780-11030e365-5f51-111a-e063-dadaa90a10e2Nortriptyline HCL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-742-60Nortriptyline HCL60 in 1 BOTTLECAPSULE602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-742NORTRIPTYLINE HCL CAPSULE NORTRIPTYLINE HCI CAPSULE [DIRECT_RX]2Legacy NDC, 1 package rows20190328_8024d787-333d-1235-e053-2991aa0a7e4c.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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEProficient Rx LP1e32f284-a5b2-4ebf-9d9e-0e9a40b46ade2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy3c57301f-5128-295e-e063-6394a90ad99e2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HCLNORTRIPTYLINE HCLDirect_rx1bcf2f7b-974f-54ad-e063-6394a90a28d92026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.27e96d6c-b311-45d2-b879-65c6a4efcfba2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY21770082-7a99-520d-e063-6394a90ab9cb2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HCLNORTRIPTYLINE HCLDirect_rx1b55fd23-36f8-10e4-e063-6394a90aa49a2026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HCLNORTRIPTYLINE HCLDirect_rx1ba55931-5597-90ea-e063-6294a90a5a2f2026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ba4edb34-82ac-4c98-8abd-fd6176838c782025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.dbb3cc4d-c36d-495d-b9fc-e5513b2f6b932025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack6b055ebf-ed9e-44c5-bc03-6b6480d143772025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.4852a754-2fc1-4c10-a414-dc8a1dfd66a22025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.c7cce83f-9508-49de-a442-246ad18ddeda2025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.f684e9c8-eca7-4e27-872d-c0adea19de9a2025-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.60763e7a-d22c-47d5-a260-f64bd4a4f6542025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC36b00c00-5fbd-c14b-e063-6294a90a49b72025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDECoupler LLC2fffe23d-37f8-34fe-e063-6294a90a7b6c2025-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDECoupler LLC2ccb3fd0-53c9-6015-e063-6294a90a3fd62025-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEAsclemed USA, Inc.b02eb04a-83ee-45b0-b755-187fde2698c32025-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDECoupler LLC2c92511f-0127-c74e-e063-6394a90a12142025-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEProficient Rx LP661ec73c-d893-446a-83c3-218b068899622024-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317136nortriptyline HCl 25 MG Oral CapsulePSN8024d787-333d-1235-e053-2991aa0a7e4c2
198046nortriptyline HCl 50 MG Oral CapsulePSN8024d787-333d-1235-e053-2991aa0a7e4c2
317136nortriptyline 25 MG Oral CapsuleSCD8024d787-333d-1235-e053-2991aa0a7e4c2
198046nortriptyline 50 MG Oral CapsuleSCD8024d787-333d-1235-e053-2991aa0a7e4c2
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY8024d787-333d-1235-e053-2991aa0a7e4c2
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSY8024d787-333d-1235-e053-2991aa0a7e4c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-742-606191907426060 CAPSULE in 1 BOTTLE (61919-742-60) 60 capsule2019-01-230000-00-00NoNoCurrent