FDA.reportPublic FDA data

Norpramin

Product NDC
30698-011
11-digit product format
306980011
Labeler code
30698
Product ID
30698-011_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
25 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESIPRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1Y58DO4MY1
Rxcui1099288, 1099290, 1099292, 1099294, 1099296, 1099298, 1099300, 1099302, 1099304, 1099306, 1099316, 1099318

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
30698-011-012025-07-03C16284748780-1f386c64a-23e9-0266-e053-dadaa90a7c1a70b562ea-9f21-4e4a-b3ed-0590b2892f6a
30698-011-012025-01-30C16284748780-1f386c64a-23e9-0266-e053-dadaa90a7c1a70b562ea-9f21-4e4a-b3ed-0590b2892f6a
30698-011-012023-12-14C16284748780-1f386c64a-23e9-0266-e053-dadaa90a7c1a70b562ea-9f21-4e4a-b3ed-0590b2892f6a
30698-011-012023-01-30C16284748780-1f386c64a-23e9-0266-e053-dadaa90a7c1a70b562ea-9f21-4e4a-b3ed-0590b2892f6a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30698-011-01Norpramin100 in 1 BOTTLETABLET, SUGAR COATED1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
30698-011-01EA - Each30698-0116ddfbce1-7f4c-4849-b4df-5e32703fc48312016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30698-011NORPRAMIN (DESIPRAMINE HYDROCHLORIDE) TABLET, SUGAR COATED [VALIDUS PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 1 package rows20231215_70b562ea-9f21-4e4a-b3ed-0590b2892f6a.zip

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
30698-011-0130698001101100 TABLET, SUGAR COATED in 1 BOTTLE (30698-011-01) 1964-11-200000-00-00NoNoCurrent