Norpramin

Product NDC
30698-015
11-digit product format
306980015
Labeler code
30698
Product ID
30698-015_3904bc92-b199-2543-e063-6294a90a81d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
desipramine hydrochloride
Dosage form
TABLET, SUGAR COATED
Route
ORAL
Labeler
Validus Pharmaceuticals LLC
Application
NDA014399
Marketing category
NDA
Marketing start
1964-11-20
Substance
DESIPRAMINE 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

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage30698-015-01IInactivated 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 packagepackage30698-015-01IInactivated 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 packagepackage30698-015-01IInactivated 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 packagepackage30698-015-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage30698-015-01UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage30698-015-01UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage30698-015-01UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
N014399-001NORPRAMINDESIPRAMINE HYDROCHLORIDE25MGTABLET / ORALRLD, Approved before 1982
N014399-003NORPRAMINDESIPRAMINE HYDROCHLORIDE50MGTABLET / ORALRLD, Approved before 1982
N014399-004NORPRAMINDESIPRAMINE HYDROCHLORIDE75MGTABLET / ORALRLD, Approved before 1982
N014399-005NORPRAMINDESIPRAMINE HYDROCHLORIDE100MGTABLET / ORALRLD, Approved before 1982
N014399-006NORPRAMINDESIPRAMINE HYDROCHLORIDE150MGTABLET / ORALRLD, Approved before 1982
N014399-007NORPRAMINDESIPRAMINE HYDROCHLORIDE10MGTABLET / ORALRLD1982-02-11

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 06:07:402026-07N014399-001NORPRAMIN25MGTABLET / ORALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N014399-003NORPRAMIN50MGTABLET / ORALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N014399-004NORPRAMIN75MGTABLET / ORALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N014399-005NORPRAMIN100MGTABLET / ORALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N014399-006NORPRAMIN150MGTABLET / ORALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N014399-007NORPRAMIN10MGTABLET / ORALRLD1982-02-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N014399-001NORPRAMIN25MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N014399-003NORPRAMIN50MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N014399-004NORPRAMIN75MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N014399-005NORPRAMIN100MGTABLET / ORALABRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N014399-006NORPRAMIN150MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N014399-007NORPRAMIN10MGTABLET / ORALABRLD1982-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N014399-001NORPRAMIN25MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N014399-003NORPRAMIN50MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N014399-004NORPRAMIN75MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N014399-005NORPRAMIN100MGTABLET / ORALABRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N014399-006NORPRAMIN150MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N014399-007NORPRAMIN10MGTABLET / ORALABRLD1982-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N014399-001NORPRAMIN25MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N014399-003NORPRAMIN50MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N014399-004NORPRAMIN75MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N014399-005NORPRAMIN100MGTABLET / ORALABRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N014399-006NORPRAMIN150MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N014399-007NORPRAMIN10MGTABLET / ORALABRLD1982-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N014399-001NORPRAMIN25MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N014399-003NORPRAMIN50MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N014399-004NORPRAMIN75MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N014399-005NORPRAMIN100MGTABLET / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N014399-006NORPRAMIN150MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N014399-007NORPRAMIN10MGTABLET / ORALABRLD1982-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N014399-001NORPRAMIN25MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N014399-003NORPRAMIN50MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N014399-004NORPRAMIN75MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N014399-005NORPRAMIN100MGTABLET / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N014399-006NORPRAMIN150MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N014399-007NORPRAMIN10MGTABLET / ORALABRLD1982-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N014399-001NORPRAMIN25MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N014399-003NORPRAMIN50MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N014399-004NORPRAMIN75MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N014399-005NORPRAMIN100MGTABLET / ORALABRLD, RS, Approved before 198203ed91905a0d…

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 UTC2026-02N014399-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N014399-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N014399-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N014399-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N014399-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N014399-007AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N014399-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N014399-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N014399-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N014399-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N014399-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N014399-007AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N014399-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N014399-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N014399-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N014399-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N014399-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N014399-007AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N014399-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N014399-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N014399-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N014399-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N014399-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N014399-007AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N014399-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N014399-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N014399-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N014399-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N014399-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N014399-007AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N014399-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N014399-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N014399-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N014399-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N014399-006AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N014399-007AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N014399-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N014399-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N014399-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N014399-005AB12680178bc6a6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESIPRAMINE HYDROCHLORIDE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1Y58DO4MY1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1099288Internal RxNorm lookup
1099290Internal RxNorm lookup
1099292Internal RxNorm lookup
1099294Internal RxNorm lookup
1099296Internal RxNorm lookup
1099298Internal RxNorm lookup
1099300Internal RxNorm lookup
1099302Internal RxNorm lookup
1099304Internal RxNorm lookup
1099306Internal RxNorm lookup
1099316Internal RxNorm lookup
1099318Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
70b562ea-9f21-4e4a-b3ed-0590b2892f6aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bda46dda-4ebd-3e63-0043-123c9d173af2Product name620220125

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30698-015-01Norpramin100 in 1 BOTTLETABLET, SUGAR COATED1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30698-015NORPRAMIN (DESIPRAMINE HYDROCHLORIDE) TABLET, SUGAR COATED [VALIDUS PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 1 package rows20231215_70b562ea-9f21-4e4a-b3ed-0590b2892f6a.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
NorpraminDESIPRAMINE HYDROCHLORIDEValidus Pharmaceuticals LLC70b562ea-9f21-4e4a-b3ed-0590b2892f6a2025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 014399
application number: NDA014399
ndc (product): 30698-015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099288desipramine HCl 10 MG Oral TabletPSN70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099292desipramine HCl 100 MG Oral TabletPSN70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099296desipramine HCl 150 MG Oral TabletPSN70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099300desipramine HCl 25 MG Oral TabletPSN70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099304desipramine HCl 50 MG Oral TabletPSN70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099316desipramine HCl 75 MG Oral TabletPSN70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099290Norpramin 10 MG Oral TabletPSN70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099294Norpramin 100 MG Oral TabletPSN70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099298Norpramin 150 MG Oral TabletPSN70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099302Norpramin 25 MG Oral TabletPSN70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099306Norpramin 50 MG Oral TabletPSN70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099318Norpramin 75 MG Oral TabletPSN70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099290desipramine hydrochloride 10 MG Oral Tablet [Norpramin]SBD70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099294desipramine hydrochloride 100 MG Oral Tablet [Norpramin]SBD70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099298desipramine hydrochloride 150 MG Oral Tablet [Norpramin]SBD70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099302desipramine hydrochloride 25 MG Oral Tablet [Norpramin]SBD70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099306desipramine hydrochloride 50 MG Oral Tablet [Norpramin]SBD70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099318desipramine hydrochloride 75 MG Oral Tablet [Norpramin]SBD70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099288desipramine hydrochloride 10 MG Oral TabletSCD70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099292desipramine hydrochloride 100 MG Oral TabletSCD70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099296desipramine hydrochloride 150 MG Oral TabletSCD70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099300desipramine hydrochloride 25 MG Oral TabletSCD70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099304desipramine hydrochloride 50 MG Oral TabletSCD70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099316desipramine hydrochloride 75 MG Oral TabletSCD70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099290Norpramin 10 MG Oral TabletSY70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099294Norpramin 100 MG Oral TabletSY70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099298Norpramin 150 MG Oral TabletSY70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099302Norpramin 25 MG Oral TabletSY70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099306Norpramin 50 MG Oral TabletSY70b562ea-9f21-4e4a-b3ed-0590b2892f6a6
1099318Norpramin 75 MG Oral TabletSY70b562ea-9f21-4e4a-b3ed-0590b2892f6a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
30698-015-0130698001501100 TABLET, SUGAR COATED in 1 BOTTLE (30698-015-01) 1964-11-200000-00-00NoNoCurrent