Nortriptyline Hydrochloride

Product NDC
70518-4017
11-digit product format
705184017
Labeler code
70518
Product ID
70518-4017_3f906a91-9a16-c7d6-e063-6394a90ab4d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA074132
Marketing category
ANDA
Marketing start
2024-02-09
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 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
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 4 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-10-29 15:01 UTC2024-10A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1995-03-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1995-03-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1995-03-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1995-03-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1995-03-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1995-03-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1995-03-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1995-03-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1995-03-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1995-03-27bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-10-29 15:01 UTC2024-10A074132-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074132-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074132-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074132-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074132-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074132-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074132-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074132-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074132-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074132-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074132-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074132-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074132-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074132-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074132-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074132-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074132-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074132-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074132-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074132-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074132-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074132-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074132-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074132-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074132-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074132-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074132-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074132-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074132-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074132-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074132-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074132-004AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074132-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074132-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074132-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074132-004AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074132-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074132-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074132-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074132-004AB1bb7c543d1eb4…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 17 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
ndc (product): 70518-4017
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
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 HYDROCHLORIDEPreferred Pharmaceuticals Inc.af950b46-07df-4de6-a221-d3d7059b87a12025-08-28Boxed 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

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

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
198045Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dd1f4d6f-14cc-44c0-b9d3-bb3d17b557faAvailable 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
70518-4017-0Nortriptyline Hydrochloride30 in 1 BLISTER PACKCAPSULE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4017NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]1Current NDC, 1 package rows20240213_dd1f4d6f-14cc-44c0-b9d3-bb3d17b557fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSNdd1f4d6f-14cc-44c0-b9d3-bb3d17b557fa2
198045nortriptyline 10 MG Oral CapsuleSCDdd1f4d6f-14cc-44c0-b9d3-bb3d17b557fa2
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYdd1f4d6f-14cc-44c0-b9d3-bb3d17b557fa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4017-07051840170030 CAPSULE in 1 BLISTER PACK (70518-4017-0) 30 capsule2024-02-09NoNoCurrent