FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
63629-3204
11-digit product format
636293204
Labeler code
63629
Product ID
63629-3204_7d1dd83e-d7a4-4349-bcc8-a3e05aad53af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074132
Marketing category
ANDA
Marketing start
1995-04-05
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A074132-001NORTRIPTYLINE HYDROCHLORIDEEQ 10MG BASECAPSULE / ORALAB1995-03-27a50c72e98297…
2026-08-01 22:54:322026-06A074132-002NORTRIPTYLINE HYDROCHLORIDEEQ 25MG BASECAPSULE / ORALAB1995-03-27a50c72e98297…
2026-08-01 22:54:322026-06A074132-003NORTRIPTYLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB1995-03-27a50c72e98297…
2026-08-01 22:54:322026-06A074132-004NORTRIPTYLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALABRS1995-03-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A074132-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A074132-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A074132-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A074132-004AB1a50c72e98297…

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 · 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
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
ndc (product): 63629-3204
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
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 · 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
43a81887-42b8-43b5-b58a-3f3df2e9949bAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-3204-12020-10-12C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-12020-10-12C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-22020-10-12C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-22020-10-12C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-32020-10-12C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-32020-10-12C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-42020-10-12C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-42020-10-12C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-52020-10-12C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-52020-10-12C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-62020-10-12C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-62020-10-12C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-12020-01-31C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-12020-01-31C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-22020-01-31C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-22020-01-31C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-32020-01-31C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-32020-01-31C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-42020-01-31C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-42020-01-31C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-52020-01-31C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-52020-01-31C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-62020-01-31C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only
63629-3204-62020-01-31C16284748780-19d75b9cf-cf71-f424-e053-dadaa90a57ceNortriptyline Hydrochloride Capsules, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-3204-1Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE301009
63629-3204-2Nortriptyline Hydrochloride60 in 1 BOTTLECAPSULE601009
63629-3204-3Nortriptyline Hydrochloride90 in 1 BOTTLECAPSULE901009
63629-3204-4Nortriptyline Hydrochloride100 in 1 BOTTLECAPSULE1001009
63629-3204-5Nortriptyline Hydrochloride120 in 1 BOTTLECAPSULE1201009
63629-3204-6Nortriptyline Hydrochloride15 in 1 BOTTLECAPSULE151009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3204-1EA - Each63629-32041bce2098-b266-4776-85c2-e455b667810512013-02-13
63629-3204-2EA - Each63629-3204d1900608-db59-457f-93cc-97bb9ca8892912013-02-13
63629-3204-3EA - Each63629-3204b87404b9-9603-4f3b-ae8e-f308e2e13d8f12013-02-13
63629-3204-4EA - Each63629-3204d3c78e72-6002-46c9-b46e-48de37d4a5a412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NORTRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT00FN6IH15DNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
NORTRIPTYLINEACTIVE MOIETYBL03SY4LXBNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1ONORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
GELATININACTIVE INGREDIENT2G86QN327LNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
SHELLACINACTIVE INGREDIENT46N107B71ONORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-3204NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1008Current NDC, Legacy NDC, 6 package rows20240320_43a81887-42b8-43b5-b58a-3f3df2e9949b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSN43a81887-42b8-43b5-b58a-3f3df2e9949b1009
198045nortriptyline 10 MG Oral CapsuleSCD43a81887-42b8-43b5-b58a-3f3df2e9949b1009
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSY43a81887-42b8-43b5-b58a-3f3df2e9949b1009

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3204-16362932040130 CAPSULE in 1 BOTTLE (63629-3204-1) 30 capsule2006-08-160000-00-00NoNoCurrent
63629-3204-26362932040260 CAPSULE in 1 BOTTLE (63629-3204-2) 60 capsule2008-10-130000-00-00NoNoCurrent
63629-3204-36362932040390 CAPSULE in 1 BOTTLE (63629-3204-3) 90 capsule2013-11-180000-00-00NoNoCurrent
63629-3204-463629320404100 CAPSULE in 1 BOTTLE (63629-3204-4) 100 capsule2021-12-220000-00-00NoNoCurrent
63629-3204-563629320405120 CAPSULE in 1 BOTTLE (63629-3204-5) 120 capsule2011-05-100000-00-00NoNoCurrent
63629-3204-66362932040615 CAPSULE in 1 BOTTLE (63629-3204-6) 15 capsule2014-06-130000-00-00NoNoCurrent