Nortriptyline Hydrochloride

Product NDC
60687-293
11-digit product format
606870293
Labeler code
60687
Product ID
60687-293_d659b0c7-e4d7-265f-e053-2a95a90adfc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA075520
Marketing category
ANDA
Marketing start
2017-07-06
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
2023-12-31
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 productproduct60687-293DDiscontinued by firm2026-08-03
excluded packagepackage60687-29360687-293-01DDiscontinued by firm2026-08-03

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 · 4 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 packagepackage60687-293-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60687-293-01f5e01cc5f278…a2eaf40c39c3…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-293-01EA - Each60687-2930f9b6008-8aa5-40a6-ac34-5ba3ecdcc10b12017-08-11
60687-293-11EA - Each60687-293b6102261-4df7-4834-b227-c4b4fe7acb7412017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-293NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AMERICAN HEALTH PACKAGING]8Legacy NDC20240809_a4bdbe16-79f8-486f-8ac5-4fa8bf4131e5.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-293-0160687029301100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-293-01) > 1 CAPSULE in 1 BLISTER PACK (60687-293-11) 100 blister pack2017-07-060000-00-00NoNoCurrent