FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
63187-798
11-digit product format
631870798
Labeler code
63187
Product ID
63187-798_4aa4c04f-3f5f-49a4-b1a6-eba6e09a588b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075520
Marketing category
ANDA
Marketing start
2000-05-08
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
50 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
A075520-001NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-05-08
A075520-002NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-05-08
A075520-003NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2000-05-08
A075520-004NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-05-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075520-001AB
A075520-002AB
A075520-003AB
A075520-004AB

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 22:54:322026-06A075520-001NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2000-05-08a50c72e98297…
2026-08-01 22:54:322026-06A075520-002NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2000-05-08a50c72e98297…
2026-08-01 22:54:322026-06A075520-003NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB2000-05-08a50c72e98297…
2026-08-01 22:54:322026-06A075520-004NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB2000-05-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075520-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075520-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A075520-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A075520-004AB1a50c72e98297…

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 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c282026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075520
application number: ANDA075520
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDENorthwind Health Company, LLCdae3314f-3128-787f-e053-2995a90aff192026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075520
application number: ANDA075520
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDENorthwind Health Company, LLC09a54dbd-6bde-3083-e063-6394a90a52972025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075520
application number: ANDA075520
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.51778813-0ec1-6b4f-e054-00144ff8d46c2024-07-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075520
application number: ANDA075520
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEA-S Medication Solutions53346b9c-40a1-4b5b-8df0-0b393661fb852024-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075520
application number: ANDA075520
NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEDIRECT RX45884cad-4a2d-44f4-93bd-16b130daf32d2024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075520
application number: ANDA075520
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEBryant Ranch Prepackcb4d1a69-60ae-4fdc-8af8-059959cf72652023-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075520
application number: ANDA075520
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEProficient Rx LP70921f99-1f25-4a8c-8269-6d5d26be7a632023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075520
application number: ANDA075520
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEProficient Rx LP59a65e6f-b812-4195-b85b-c412fb902c932022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075520
application number: ANDA075520
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEProficient Rx LPc5b1ef5e-9681-426a-abf6-60d9c28d92a02022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075520
application number: ANDA075520
ndc (product): 63187-798

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORTRIPTYLINE HYDROCHLORIDE50 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
198046Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c5b1ef5e-9681-426a-abf6-60d9c28d92a0Available 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
63187-798-30Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE304
63187-798-60Nortriptyline Hydrochloride60 in 1 BOTTLECAPSULE604
63187-798-90Nortriptyline Hydrochloride90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-798-30EA - Each63187-7987fe742b8-905a-4c71-ba24-1c2f411bf7ec12017-03-06
63187-798-60EA - Each63187-7980fda06a3-04d3-40b3-831a-994f63d8841412020-05-08
63187-798-90EA - Each63187-79827faead4-de61-4ceb-af8b-41bb77306b4212021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-798NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20220616_c5b1ef5e-9681-426a-abf6-60d9c28d92a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198046nortriptyline HCl 50 MG Oral CapsulePSNc5b1ef5e-9681-426a-abf6-60d9c28d92a04
198046nortriptyline 50 MG Oral CapsuleSCDc5b1ef5e-9681-426a-abf6-60d9c28d92a04
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYc5b1ef5e-9681-426a-abf6-60d9c28d92a04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-798-306318707983030 CAPSULE in 1 BOTTLE (63187-798-30) 30 capsule2017-01-010000-00-00NoNoCurrent
63187-798-606318707986060 CAPSULE in 1 BOTTLE (63187-798-60) 60 capsule2017-01-010000-00-00NoNoCurrent
63187-798-906318707989090 CAPSULE in 1 BOTTLE (63187-798-90) 90 capsule2017-01-010000-00-00NoNoCurrent