Imipramine Hydrochloride

Product NDC
68151-2768
11-digit product format
681512768
Labeler code
68151
Product ID
68151-2768_080d3af1-eb4a-4c23-bcb5-b30c26750861
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imipramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA088292
Marketing category
ANDA
Marketing start
1983-10-21
Marketing end
0000-00-00
Substance
IMIPRAMINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct68151-2768IInactivated by FDA2026-08-17
excluded packagepackage68151-276868151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0IInactivated 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 packagepackage68151-2768-0EExcluded 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A088292-001IMIPRAMINE HYDROCHLORIDEIMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A088292-001AB

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-213f01610625f2…
2019-09-15 20:21 UTC2019-09A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088292-001IMIPRAMINE HYDROCHLORIDE10MGTABLET / ORALAB1983-10-21e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A088292-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A088292-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088292-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A088292-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088292-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088292-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088292-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088292-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088292-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088292-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088292-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088292-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088292-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088292-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088292-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088292-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088292-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088292-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088292-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088292-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088292-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088292-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A088292-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088292-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088292-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088292-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A088292-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088292-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088292-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088292-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088292-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088292-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088292-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088292-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088292-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A088292-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A088292-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088292-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088292-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088292-001AB1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a0e0df1b-51aa-4301-873c-732ab0ec1631Product name120170614
0c52f100-e529-4cfc-bd59-334f3eea0233Product name120151110

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-2768-02020-01-31C16284748780-19d75b9d0-73d5-f424-e053-dadaa90a57ce92ca69d4-cdba-4789-91a9-922664d52498

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-2768-0Imipramine Hydrochloride1 in 1 PACKAGETABLET12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IMIPRAMINE HYDROCHLORIDEACTIVE INGREDIENTBKE5Q1J60UIMIPRAMINE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2
IMIPRAMINEACTIVE MOIETYOGG85SX4E4IMIPRAMINE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-2768IMIPRAMINE HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20140815_92ca69d4-cdba-4789-91a9-922664d52498.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Imipramine HydrochlorideIMIPRAMINE HYDROCHLORIDEStrides Pharma Science Limited51d3b181-0d15-4782-a966-feb137972b182026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088292
application number: ANDA088292

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835593imipramine HCl 10 MG Oral TabletPSN92ca69d4-cdba-4789-91a9-922664d524982
835593imipramine hydrochloride 10 MG Oral TabletSCD92ca69d4-cdba-4789-91a9-922664d524982

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-2768-0681512768001 in 1 PACKAGEHistorical