Nortriptyline Hydrochloride

Product NDC
76420-910
11-digit product format
764200910
Labeler code
76420
Product ID
76420-910_2cbda9e6-b8cc-1364-e063-6294a90ace66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA073556
Marketing category
ANDA
Marketing start
2023-11-17
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
10 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 43.

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A073556-001NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1992-03-3084e616aacf4f…
2026-09-14 22:38:342026-08A073556-002NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1992-03-3084e616aacf4f…
2026-09-14 22:38:342026-08A073556-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1992-03-3084e616aacf4f…
2026-09-14 22:38:342026-08A073556-004NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1992-03-3084e616aacf4f…
2026-08-18 06:07:402026-07A073556-001NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1992-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07A073556-002NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1992-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07A073556-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1992-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07A073556-004NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1992-03-30caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A073556-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A073556-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A073556-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A073556-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A073556-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A073556-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A073556-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A073556-004AB1caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORTRIPTYLINE HYDROCHLORIDE10 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198045Internal RxNorm lookup
198046Internal RxNorm lookup
198047Internal RxNorm lookup
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
b02eb04a-83ee-45b0-b755-187fde2698c3Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-910-01Nortriptyline Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE1001
76420-910-05Nortriptyline Hydrochloride500 in 1 BOTTLE, PLASTICCAPSULE5001
76420-910-30Nortriptyline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE301
76420-910-60Nortriptyline Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE601
76420-910-90Nortriptyline Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-910NORTRIPTYLINE HYDROCHLORIDE CAPSULE [ASCLEMED USA, INC.]1Current NDC, 5 package rows20250130_b02eb04a-83ee-45b0-b755-187fde2698c3.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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEA-S Medication Solutions8a294b63-7268-4105-8e17-a59ef889d5722024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLC1a904ddf-574a-8a24-e063-6394a90aba3b2024-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack4442f029-dd5e-4834-9b01-eb8c638ce4b12024-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack8811104b-6223-4ea6-a9c6-61d63a21b3cd2024-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEDr. Reddy's Laboratories Inc.b1d9582c-742c-91a8-c2b3-bbdb212204702023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEMayne Pharma Inc.765d726b-fd4b-4ef7-afd7-9e7e9bf8cae62021-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSNb02eb04a-83ee-45b0-b755-187fde2698c31
317136nortriptyline HCl 25 MG Oral CapsulePSNb02eb04a-83ee-45b0-b755-187fde2698c31
198046nortriptyline HCl 50 MG Oral CapsulePSNb02eb04a-83ee-45b0-b755-187fde2698c31
198047nortriptyline HCl 75 MG Oral CapsulePSNb02eb04a-83ee-45b0-b755-187fde2698c31
198045nortriptyline 10 MG Oral CapsuleSCDb02eb04a-83ee-45b0-b755-187fde2698c31
317136nortriptyline 25 MG Oral CapsuleSCDb02eb04a-83ee-45b0-b755-187fde2698c31
198046nortriptyline 50 MG Oral CapsuleSCDb02eb04a-83ee-45b0-b755-187fde2698c31
198047nortriptyline 75 MG Oral CapsuleSCDb02eb04a-83ee-45b0-b755-187fde2698c31
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYb02eb04a-83ee-45b0-b755-187fde2698c31
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYb02eb04a-83ee-45b0-b755-187fde2698c31
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYb02eb04a-83ee-45b0-b755-187fde2698c31
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSYb02eb04a-83ee-45b0-b755-187fde2698c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-910-0176420091001100 CAPSULE in 1 BOTTLE, PLASTIC (76420-910-01) 100 capsule2025-01-28NoNoCurrent
76420-910-0576420091005500 CAPSULE in 1 BOTTLE, PLASTIC (76420-910-05) 500 capsule2025-01-28NoNoCurrent
76420-910-307642009103030 CAPSULE in 1 BOTTLE, PLASTIC (76420-910-30) 30 capsule2025-01-28NoNoCurrent
76420-910-607642009106060 CAPSULE in 1 BOTTLE, PLASTIC (76420-910-60) 60 capsule2025-01-28NoNoCurrent
76420-910-907642009109090 CAPSULE in 1 BOTTLE, PLASTIC (76420-910-90) 90 capsule2025-01-28NoNoCurrent