Amitriptyline Hydrochloride

Product NDC
60687-433
11-digit product format
606870433
Labeler code
60687
Product ID
60687-433_44706732-5523-8018-e063-6294a90a9cc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA210086
Marketing category
ANDA
Marketing start
2019-08-15
Substance
AMITRIPTYLINE 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210086-001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2017-10-06
A210086-002AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2017-10-06
A210086-003AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-06
A210086-004AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2017-10-06
A210086-005AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-06
A210086-006AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A210086-001AB
A210086-002AB
A210086-003AB
A210086-004AB
A210086-005AB
A210086-006AB

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210086-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2017-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210086-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2017-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210086-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210086-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2017-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210086-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210086-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210086-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2017-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210086-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2017-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210086-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210086-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2017-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210086-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210086-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A210086-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2017-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210086-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2017-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210086-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210086-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2017-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210086-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210086-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210086-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2017-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210086-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2017-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210086-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210086-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2017-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210086-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210086-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210086-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2017-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210086-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2017-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210086-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210086-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2017-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210086-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210086-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210086-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2017-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210086-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2017-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210086-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210086-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2017-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210086-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORALAB2017-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210086-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORALAB2017-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210086-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORALAB2017-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210086-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORALAB2017-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210086-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORALAB2017-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210086-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORALAB2017-10-062680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210086-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210086-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210086-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210086-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210086-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210086-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210086-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210086-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210086-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210086-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210086-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210086-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210086-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210086-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210086-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210086-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210086-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210086-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210086-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210086-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210086-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210086-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210086-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210086-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210086-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210086-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210086-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210086-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210086-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210086-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210086-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210086-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210086-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210086-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210086-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210086-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210086-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210086-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210086-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210086-004AB12680178bc6a6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMITRIPTYLINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
26LUD4JO9KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
856834Internal RxNorm lookup
856845Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
98cc0bf3-ae5b-47cc-992f-9157fed7c3f4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e5006e90-7f2e-4341-bcdb-f83027a8fc39Product name620240611
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-433-01Amitriptyline Hydrochloride100 in 1 BOX, UNIT-DOSETABLET, FILM COATED1007
60687-433-11Amitriptyline Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-433-01EA - Each60687-4333bad941c-f35e-4e53-984f-9dd36daa0ebb12019-08-06
60687-433-11EA - Each60687-433dec74ede-df2b-4fc0-9a9a-f96266f73d4b12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-433AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20240926_98cc0bf3-ae5b-47cc-992f-9157fed7c3f4.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDECoupler LLC5070fa18-ecc9-de14-e063-6394a90a372e2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210086
application number: ANDA210086
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAmerican Health Packaging98cc0bf3-ae5b-47cc-992f-9157fed7c3f42025-11-25Boxed warning, Adverse reactionsExact identifier
application applno (ANDA): 210086
application number: ANDA210086
ndc (product): 60687-433
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.43454445-b9cf-1378-e063-6294a90a1cc62025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210086
application number: ANDA210086
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEZydus Lifesciences Limited4159b10e-f589-486c-969d-9b4544b098b52025-10-04Exact identifier
application applno (ANDA): 210086
application number: ANDA210086
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDENorthstar Rx LLC.8ed28f42-e41a-45ca-a86f-849ebeb6ab802025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210086
application number: ANDA210086
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.73669354-babc-4687-a4fe-ad0fc1f863ba2025-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210086
application number: ANDA210086
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutionsb793f1f8-c1f9-46f0-8156-1a4957db3a1f2024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210086
application number: ANDA210086
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions0067b698-ee1d-4524-b1cc-af1028d137362024-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210086
application number: ANDA210086
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions5e8c8c5f-4964-4642-ad4b-69a75b2c8a022023-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210086
application number: ANDA210086
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutionsd22879c5-925a-42e0-9d48-55a4221929832023-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210086
application number: ANDA210086

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856834amitriptyline HCl 25 MG Oral TabletPSN98cc0bf3-ae5b-47cc-992f-9157fed7c3f47
856845amitriptyline HCl 50 MG Oral TabletPSN98cc0bf3-ae5b-47cc-992f-9157fed7c3f47
856834amitriptyline hydrochloride 25 MG Oral TabletSCD98cc0bf3-ae5b-47cc-992f-9157fed7c3f47
856845amitriptyline hydrochloride 50 MG Oral TabletSCD98cc0bf3-ae5b-47cc-992f-9157fed7c3f47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-433-0160687043301100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-433-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-433-11) 100 blister pack2019-08-150000-00-00NoNoCurrent
60687-433-11606870433111 in 1 BLISTER PACKHistorical