FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
75907-070
11-digit product format
759070070
Labeler code
75907
Product ID
75907-070_8630467c-de24-9d2e-ac96-ce9afeaca9b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA073556
Marketing category
ANDA
Marketing start
2023-11-17
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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A073556-001NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1992-03-30a50c72e98297…
2026-08-01 22:54:322026-06A073556-002NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1992-03-30a50c72e98297…
2026-08-01 22:54:322026-06A073556-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1992-03-30a50c72e98297…
2026-08-01 22:54:322026-06A073556-004NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1992-03-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A073556-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A073556-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A073556-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A073556-004AB1a50c72e98297…

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEProficient Rx LP1e32f284-a5b2-4ebf-9d9e-0e9a40b46ade2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy3c57301f-5128-295e-e063-6394a90ad99e2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HCLNORTRIPTYLINE HCLDirect_rx1bcf2f7b-974f-54ad-e063-6394a90a28d92026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.27e96d6c-b311-45d2-b879-65c6a4efcfba2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY21770082-7a99-520d-e063-6394a90ab9cb2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HCLNORTRIPTYLINE HCLDirect_rx1b55fd23-36f8-10e4-e063-6394a90aa49a2026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HCLNORTRIPTYLINE HCLDirect_rx1ba55931-5597-90ea-e063-6294a90a5a2f2026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ba4edb34-82ac-4c98-8abd-fd6176838c782025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.dbb3cc4d-c36d-495d-b9fc-e5513b2f6b932025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack6b055ebf-ed9e-44c5-bc03-6b6480d143772025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.4852a754-2fc1-4c10-a414-dc8a1dfd66a22025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.c7cce83f-9508-49de-a442-246ad18ddeda2025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.f684e9c8-eca7-4e27-872d-c0adea19de9a2025-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.60763e7a-d22c-47d5-a260-f64bd4a4f6542025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC36b00c00-5fbd-c14b-e063-6294a90a49b72025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDECoupler LLC2fffe23d-37f8-34fe-e063-6294a90a7b6c2025-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDECoupler LLC2ccb3fd0-53c9-6015-e063-6294a90a3fd62025-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEAsclemed USA, Inc.b02eb04a-83ee-45b0-b755-187fde2698c32025-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDECoupler LLC2c92511f-0127-c74e-e063-6394a90a12142025-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEProficient Rx LP661ec73c-d893-446a-83c3-218b068899622024-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073556
application number: ANDA073556

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 · 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
b1d9582c-742c-91a8-c2b3-bbdb21220470Available 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75907-070-01Nortriptyline Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE1001
75907-070-05Nortriptyline Hydrochloride500 in 1 BOTTLE, PLASTICCAPSULE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75907-070-01EA - Each75907-07049694223-7c1d-4697-844b-2af76352bf7912024-02-14
75907-070-05EA - Each75907-0708d46e78e-7242-4329-8c0f-934c09ba816812024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75907-070NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES INC.]1Current NDC, 2 package rows20231117_b1d9582c-742c-91a8-c2b3-bbdb21220470.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317136nortriptyline HCl 25 MG Oral CapsulePSN8811104b-6223-4ea6-a9c6-61d63a21b3cd100
317136nortriptyline 25 MG Oral CapsuleSCD8811104b-6223-4ea6-a9c6-61d63a21b3cd100
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY8811104b-6223-4ea6-a9c6-61d63a21b3cd100
317136nortriptyline HCl 25 MG Oral CapsulePSN1b55fd23-36f8-10e4-e063-6394a90aa49a4
317136nortriptyline 25 MG Oral CapsuleSCD1b55fd23-36f8-10e4-e063-6394a90aa49a4
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY1b55fd23-36f8-10e4-e063-6394a90aa49a4
317136nortriptyline HCl 25 MG Oral CapsulePSNdbb3cc4d-c36d-495d-b9fc-e5513b2f6b933
317136nortriptyline 25 MG Oral CapsuleSCDdbb3cc4d-c36d-495d-b9fc-e5513b2f6b933
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYdbb3cc4d-c36d-495d-b9fc-e5513b2f6b933
317136nortriptyline HCl 25 MG Oral CapsulePSNf684e9c8-eca7-4e27-872d-c0adea19de9a2
317136nortriptyline HCl 25 MG Oral CapsulePSN8a294b63-7268-4105-8e17-a59ef889d5722
317136nortriptyline HCl 25 MG Oral CapsulePSN3c57301f-5128-295e-e063-6394a90ad99e2
317136nortriptyline 25 MG Oral CapsuleSCDf684e9c8-eca7-4e27-872d-c0adea19de9a2
317136nortriptyline 25 MG Oral CapsuleSCD8a294b63-7268-4105-8e17-a59ef889d5722
317136nortriptyline 25 MG Oral CapsuleSCD3c57301f-5128-295e-e063-6394a90ad99e2
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY3c57301f-5128-295e-e063-6394a90ad99e2
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY8a294b63-7268-4105-8e17-a59ef889d5722
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYf684e9c8-eca7-4e27-872d-c0adea19de9a2
198045nortriptyline HCl 10 MG Oral CapsulePSNb1d9582c-742c-91a8-c2b3-bbdb212204701
198045nortriptyline HCl 10 MG Oral CapsulePSNb02eb04a-83ee-45b0-b755-187fde2698c31
317136nortriptyline HCl 25 MG Oral CapsulePSN661ec73c-d893-446a-83c3-218b068899621
317136nortriptyline HCl 25 MG Oral CapsulePSN36b00c00-5fbd-c14b-e063-6294a90a49b71
317136nortriptyline HCl 25 MG Oral CapsulePSNb1d9582c-742c-91a8-c2b3-bbdb212204701
317136nortriptyline HCl 25 MG Oral CapsulePSN2c92511f-0127-c74e-e063-6394a90a12141
317136nortriptyline HCl 25 MG Oral CapsulePSNb02eb04a-83ee-45b0-b755-187fde2698c31
317136nortriptyline HCl 25 MG Oral CapsulePSN1a904ddf-574a-8a24-e063-6394a90aba3b1
198046nortriptyline HCl 50 MG Oral CapsulePSNb1d9582c-742c-91a8-c2b3-bbdb212204701
198046nortriptyline HCl 50 MG Oral CapsulePSNb02eb04a-83ee-45b0-b755-187fde2698c31
198047nortriptyline HCl 75 MG Oral CapsulePSNb1d9582c-742c-91a8-c2b3-bbdb212204701
198047nortriptyline HCl 75 MG Oral CapsulePSNb02eb04a-83ee-45b0-b755-187fde2698c31
198045nortriptyline 10 MG Oral CapsuleSCDb1d9582c-742c-91a8-c2b3-bbdb212204701
198045nortriptyline 10 MG Oral CapsuleSCDb02eb04a-83ee-45b0-b755-187fde2698c31
317136nortriptyline 25 MG Oral CapsuleSCDb1d9582c-742c-91a8-c2b3-bbdb212204701
317136nortriptyline 25 MG Oral CapsuleSCD36b00c00-5fbd-c14b-e063-6294a90a49b71
317136nortriptyline 25 MG Oral CapsuleSCD661ec73c-d893-446a-83c3-218b068899621
317136nortriptyline 25 MG Oral CapsuleSCD2c92511f-0127-c74e-e063-6394a90a12141
317136nortriptyline 25 MG Oral CapsuleSCD1a904ddf-574a-8a24-e063-6394a90aba3b1
317136nortriptyline 25 MG Oral CapsuleSCDb02eb04a-83ee-45b0-b755-187fde2698c31
198046nortriptyline 50 MG Oral CapsuleSCDb1d9582c-742c-91a8-c2b3-bbdb212204701
198046nortriptyline 50 MG Oral CapsuleSCDb02eb04a-83ee-45b0-b755-187fde2698c31
198047nortriptyline 75 MG Oral CapsuleSCDb02eb04a-83ee-45b0-b755-187fde2698c31
198047nortriptyline 75 MG Oral CapsuleSCDb1d9582c-742c-91a8-c2b3-bbdb212204701
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYb1d9582c-742c-91a8-c2b3-bbdb212204701
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYb02eb04a-83ee-45b0-b755-187fde2698c31
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY1a904ddf-574a-8a24-e063-6394a90aba3b1
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY2c92511f-0127-c74e-e063-6394a90a12141
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY36b00c00-5fbd-c14b-e063-6294a90a49b71
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSY661ec73c-d893-446a-83c3-218b068899621
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYb1d9582c-742c-91a8-c2b3-bbdb212204701
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYb02eb04a-83ee-45b0-b755-187fde2698c31
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYb1d9582c-742c-91a8-c2b3-bbdb212204701
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYb02eb04a-83ee-45b0-b755-187fde2698c31
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSYb1d9582c-742c-91a8-c2b3-bbdb212204701
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
75907-070-0175907007001100 CAPSULE in 1 BOTTLE, PLASTIC (75907-070-01) 100 capsule2023-11-17NoNoCurrent
75907-070-0575907007005500 CAPSULE in 1 BOTTLE, PLASTIC (75907-070-05) 500 capsule2023-11-17NoNoCurrent