Nortriptyline Hydrochloride

Product NDC
63187-396
11-digit product format
631870396
Labeler code
63187
Product ID
63187-396_18775e95-6eef-4cec-bf3f-3a9d5e8550d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075520
Marketing category
ANDA
Marketing start
2000-05-08
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORTRIPTYLINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
00FN6IH15DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
317136Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
59a65e6f-b812-4195-b85b-c412fb902c93Available on FDA.report

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
63187-396-30Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE305
63187-396-60Nortriptyline Hydrochloride60 in 1 BOTTLECAPSULE605
63187-396-90Nortriptyline Hydrochloride90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-396-30EA - Each63187-396af6c7c08-ed30-45c8-bb4d-1ef54aeed03412017-11-06
63187-396-60EA - Each63187-396f44411b0-9b92-4380-a758-813a083caac912017-03-06
63187-396-90EA - Each63187-396e9075e17-52d1-475b-a771-2af7cebfd55412019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-396NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20220716_59a65e6f-b812-4195-b85b-c412fb902c93.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
ndc (product): 63187-396
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 CapsulePSN59a65e6f-b812-4195-b85b-c412fb902c935
317136nortriptyline 25 MG Oral CapsuleSCD59a65e6f-b812-4195-b85b-c412fb902c935
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY59a65e6f-b812-4195-b85b-c412fb902c935

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-396-306318703963030 CAPSULE in 1 BOTTLE (63187-396-30) 30 capsule2016-10-030000-00-00NoNoCurrent
63187-396-606318703966060 CAPSULE in 1 BOTTLE (63187-396-60) 60 capsule2016-10-030000-00-00NoNoCurrent
63187-396-906318703969090 CAPSULE in 1 BOTTLE (63187-396-90) 90 capsule2016-10-030000-00-00NoNoCurrent