Nortriptyline Hydrochloride

Product NDC
60687-900
11-digit product format
606870900
Labeler code
60687
Product ID
60687-900_5c9142d7-26af-c2e6-e063-6294a90a6716
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA074132
Marketing category
ANDA
Marketing start
2025-12-08
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A074132-001NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-27
A074132-002NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-27
A074132-003NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-27
A074132-004NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRS1995-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074132-001AB
A074132-002AB
A074132-003AB
A074132-004AB

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 22:38:342026-08A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-2784e616aacf4f…
2026-09-14 22:38:342026-08A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRS1995-03-2784e616aacf4f…
2026-08-18 06:07:402026-07A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-27caaa826d4ba7…
2026-08-18 06:07:402026-07A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRS1995-03-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRS1995-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRS1995-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRS1995-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRS1995-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRS1995-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRS1995-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1995-03-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1995-03-275bbf6a4d5a75…

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 22:38:342026-08A074132-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A074132-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A074132-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A074132-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A074132-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074132-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074132-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074132-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074132-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074132-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074132-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074132-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074132-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074132-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074132-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074132-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074132-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074132-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074132-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074132-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074132-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074132-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074132-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074132-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074132-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074132-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074132-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074132-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074132-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074132-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074132-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074132-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074132-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074132-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074132-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074132-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074132-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074132-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074132-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074132-004AB15bbf6a4d5a75…

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORTRIPTYLINE HYDROCHLORIDE10 mg/1

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
60687-900-01Nortriptyline Hydrochloride100 in 1 CARTONCAPSULE1001
60687-900-11Nortriptyline Hydrochloride1 in 1 BLISTER PACKCAPSULE11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-900-01EA - Each60687-90091c161ba-ec56-48a0-8ebe-8bec70d205d712025-12-16
60687-900-11EA - Each60687-9005ff5a62a-2be1-4f88-83f2-52d700ae878812025-12-16

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.dd1f4d6f-14cc-44c0-b9d3-bb3d17b557fa2026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.522d0cd8-d84d-4961-a525-4527fce44c3c2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEA-S Medication Solutionsa2cf7783-7019-49ea-ab55-796674d945462026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack8eef261f-5c78-a88f-37c4-46e6b0e0f0ee2026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDECoupler LLC4c21abdb-f3e9-9037-e063-6294a90af4b42026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEDirect Rx017f7717-e160-4142-9a5a-1a2bd97767072026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEAmerican Health Packagingd111c36d-98ed-4f0d-97ea-86fe9048deee2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
ndc (product): 60687-900
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEA-S Medication Solutions686d15d0-6434-42ec-8c78-f45d617d294c2025-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack962f3f54-0556-4509-a231-ca62cb01bec82025-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack43a81887-42b8-43b5-b58a-3f3df2e9949b2025-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.b58d473a-b19f-4d2a-b1ae-dd398d7a29e12025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEProficient Rx LPe047f990-c374-4f8f-8583-c615f92545e22024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEProficient Rx LP2f9fc7a0-163a-4a05-84a7-7999a41ecb1f2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEProficient Rx LPb387ba49-fd3f-4488-86e8-9b81e85ab2322024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCf1868790-c70b-4979-974d-3ce0ffe99e362024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEProficient Rx LP30263e15-de21-4db4-aceb-59d619909e822023-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074132
application number: ANDA074132

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSNd111c36d-98ed-4f0d-97ea-86fe9048deee1
317136nortriptyline HCl 25 MG Oral CapsulePSNd111c36d-98ed-4f0d-97ea-86fe9048deee1
198045nortriptyline 10 MG Oral CapsuleSCDd111c36d-98ed-4f0d-97ea-86fe9048deee1
317136nortriptyline 25 MG Oral CapsuleSCDd111c36d-98ed-4f0d-97ea-86fe9048deee1
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYd111c36d-98ed-4f0d-97ea-86fe9048deee1
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYd111c36d-98ed-4f0d-97ea-86fe9048deee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-900-0160687090001100 BLISTER PACK in 1 CARTON (60687-900-01) / 1 CAPSULE in 1 BLISTER PACK (60687-900-11) 100 blister pack2025-12-08NoNoCurrent
60687-900-11606870900111 in 1 BLISTER PACKHistorical