Elavil 25 mg

Product NDC
69874-422
11-digit product format
698740422
Labeler code
69874
Product ID
69874-422_695e19d0-b09e-4d68-8466-19e1a0a644c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMITRIPTYLINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Thompson Medical Solutions Llc
Application
ANDA040218
Marketing category
ANDA
Marketing start
1997-09-11
Marketing end
0000-00-00
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69874-422IInactivated by FDA2026-08-17
excluded packagepackage69874-42269874-422-10IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69874-422-10IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69874-422-10IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69874-422-10IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69874-422-10IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69874-422-10IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69874-422-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69874-422-10IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69874-422-10IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69874-422-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69874-422-10IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69874-422-10IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69874-422-10IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69874-422-10IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69874-422-10IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69874-422-10IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69874-422-10IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69874-422-10IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69874-422-10IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage69874-422-10IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69874-422-10IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69874-422-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage69874-422-10EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040218-001AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-11
A040218-002AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-11
A040218-003AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-11
A040218-004AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-11
A040218-005AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-11
A040218-006AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-11

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 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A040218-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-08-18 06:07:402026-07A040218-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040218-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040218-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040218-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040218-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040218-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040218-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040218-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040218-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040218-005AMITRIPTYLINE HYDROCHLORIDE100MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040218-006AMITRIPTYLINE HYDROCHLORIDE150MGTABLET / ORAL1997-09-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040218-001AMITRIPTYLINE HYDROCHLORIDE10MGTABLET / ORAL1997-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040218-002AMITRIPTYLINE HYDROCHLORIDE25MGTABLET / ORAL1997-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040218-003AMITRIPTYLINE HYDROCHLORIDE50MGTABLET / ORAL1997-09-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040218-004AMITRIPTYLINE HYDROCHLORIDE75MGTABLET / ORAL1997-09-1103ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040218-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040218-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040218-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040218-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040218-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040218-006AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040218-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040218-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040218-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040218-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040218-005AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040218-006AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040218-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040218-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040218-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040218-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040218-005AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040218-006AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040218-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040218-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040218-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040218-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040218-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040218-006AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040218-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040218-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040218-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040218-004AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040218-005AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040218-006AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040218-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040218-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040218-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040218-004AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040218-005AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040218-006AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040218-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040218-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040218-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040218-004AB187673890dc5c…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69874-422-102020-01-31C16284748780-19d75b9d0-4beb-f424-e053-dadaa90a57ceELAVIL TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69874-422-10Elavil 25 mg100 in 1 BOTTLE, PLASTICTABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69874-422-10EA - Each69874-4228605e366-941a-4e94-a5e8-375a956feab012016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69874-422ELAVIL 25 MG (AMITRIPTYLINE HYDROCHLORIDE) TABLET [THOMPSON MEDICAL SOLUTIONS LLC]1Legacy NDC, 1 package rows20160419_cb986e14-d618-4021-91d7-599e038d9d39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856834amitriptyline HCl 25 MG Oral TabletPSNcb986e14-d618-4021-91d7-599e038d9d391
856836Elavil 25 MG Oral TabletPSNcb986e14-d618-4021-91d7-599e038d9d391
856836amitriptyline hydrochloride 25 MG Oral Tablet [Elavil]SBDcb986e14-d618-4021-91d7-599e038d9d391
856834amitriptyline hydrochloride 25 MG Oral TabletSCDcb986e14-d618-4021-91d7-599e038d9d391
856836Elavil 25 MG Oral TabletSYcb986e14-d618-4021-91d7-599e038d9d391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69874-422-1069874042210100 in 1 BOTTLE, PLASTICHistorical