FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
70710-1153
11-digit product format
707101153
Labeler code
70710
Product ID
70710-1153_eb495cd8-4bb8-40f5-b578-5e5b9d49b772
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA213441
Marketing category
ANDA
Marketing start
2022-02-10
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
A213441-001NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL2021-02-24
A213441-002NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORAL2021-02-24
A213441-003NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORAL2021-02-24
A213441-004NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORAL2021-02-24

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 22:54:322026-06A213441-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORAL2021-02-24a50c72e98297…
2026-08-01 22:54:322026-06A213441-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORAL2021-02-24a50c72e98297…
2026-08-01 22:54:322026-06A213441-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORAL2021-02-24a50c72e98297…
2026-08-01 22:54:322026-06A213441-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORAL2021-02-24a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEZydus Lifesciences Limitedf22dce73-b895-4fe2-8cf7-816dca93c2462024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213441
application number: ANDA213441
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.dbe85bdc-17a1-4201-bf48-a52e35d69b682024-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213441
application number: ANDA213441
ndc (product): 70710-1153

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
dbe85bdc-17a1-4201-bf48-a52e35d69b68Available 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
70710-1153-1Nortriptyline Hydrochloride100 in 1 BOTTLECAPSULE1002
70710-1153-3Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE302
70710-1153-5Nortriptyline Hydrochloride500 in 1 BOTTLECAPSULE5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1153NORTRIPTYLINE HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]2Current NDC, Legacy NDC, 3 package rows20240328_dbe85bdc-17a1-4201-bf48-a52e35d69b68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSNdbe85bdc-17a1-4201-bf48-a52e35d69b682
317136nortriptyline HCl 25 MG Oral CapsulePSNdbe85bdc-17a1-4201-bf48-a52e35d69b682
198046nortriptyline HCl 50 MG Oral CapsulePSNdbe85bdc-17a1-4201-bf48-a52e35d69b682
198047nortriptyline HCl 75 MG Oral CapsulePSNdbe85bdc-17a1-4201-bf48-a52e35d69b682
198045nortriptyline 10 MG Oral CapsuleSCDdbe85bdc-17a1-4201-bf48-a52e35d69b682
317136nortriptyline 25 MG Oral CapsuleSCDdbe85bdc-17a1-4201-bf48-a52e35d69b682
198046nortriptyline 50 MG Oral CapsuleSCDdbe85bdc-17a1-4201-bf48-a52e35d69b682
198047nortriptyline 75 MG Oral CapsuleSCDdbe85bdc-17a1-4201-bf48-a52e35d69b682
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYdbe85bdc-17a1-4201-bf48-a52e35d69b682
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYdbe85bdc-17a1-4201-bf48-a52e35d69b682
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYdbe85bdc-17a1-4201-bf48-a52e35d69b682
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSYdbe85bdc-17a1-4201-bf48-a52e35d69b682

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1153-170710115301100 CAPSULE in 1 BOTTLE (70710-1153-1) 100 capsule2022-02-100000-00-00NoNoCurrent
70710-1153-37071011530330 CAPSULE in 1 BOTTLE (70710-1153-3) 30 capsule2022-02-100000-00-00NoNoCurrent
70710-1153-570710115305500 CAPSULE in 1 BOTTLE (70710-1153-5) 500 capsule2022-02-100000-00-00NoNoCurrent