Home NDC 30698-020-01 Norpramin
Product NDC 30698-020
Requested package NDC 30698-020-01
11-digit product format 306980020
Labeler code 30698
Product ID 30698-020_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 100 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 · 7 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N014399-001 NORPRAMIN DESIPRAMINE HYDROCHLORIDE 25MG TABLET / ORAL RLD, Approved before 1982 N014399-003 NORPRAMIN DESIPRAMINE HYDROCHLORIDE 50MG TABLET / ORAL RLD, Approved before 1982 N014399-004 NORPRAMIN DESIPRAMINE HYDROCHLORIDE 75MG TABLET / ORAL RLD, Approved before 1982 N014399-005 NORPRAMIN DESIPRAMINE HYDROCHLORIDE 100MG TABLET / ORAL RLD, Approved before 1982 N014399-006 NORPRAMIN DESIPRAMINE HYDROCHLORIDE 150MG TABLET / ORAL RLD, Approved before 1982 N014399-007 NORPRAMIN DESIPRAMINE HYDROCHLORIDE 10MG TABLET / ORAL RLD 1982-02-11
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 · 258 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N014399-001 NORPRAMIN 25MG TABLET / ORAL RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N014399-003 NORPRAMIN 50MG TABLET / ORAL RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N014399-004 NORPRAMIN 75MG TABLET / ORAL RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N014399-005 NORPRAMIN 100MG TABLET / ORAL RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N014399-006 NORPRAMIN 150MG TABLET / ORAL RLD, Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N014399-007 NORPRAMIN 10MG TABLET / ORAL RLD 1982-02-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N014399-001 NORPRAMIN 25MG TABLET / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N014399-003 NORPRAMIN 50MG TABLET / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N014399-004 NORPRAMIN 75MG TABLET / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N014399-005 NORPRAMIN 100MG TABLET / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N014399-006 NORPRAMIN 150MG TABLET / ORAL RLD, Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N014399-007 NORPRAMIN 10MG TABLET / ORAL RLD 1982-02-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N014399-001 NORPRAMIN 25MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N014399-003 NORPRAMIN 50MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N014399-004 NORPRAMIN 75MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N014399-005 NORPRAMIN 100MG TABLET / ORAL AB RLD, RS, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N014399-006 NORPRAMIN 150MG TABLET / ORAL AB RLD, Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N014399-007 NORPRAMIN 10MG TABLET / ORAL AB RLD 1982-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N014399-001 NORPRAMIN 25MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N014399-003 NORPRAMIN 50MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N014399-004 NORPRAMIN 75MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N014399-005 NORPRAMIN 100MG TABLET / ORAL AB RLD, RS, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N014399-006 NORPRAMIN 150MG TABLET / ORAL AB RLD, Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N014399-007 NORPRAMIN 10MG TABLET / ORAL AB RLD 1982-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N014399-001 NORPRAMIN 25MG TABLET / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N014399-003 NORPRAMIN 50MG TABLET / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N014399-004 NORPRAMIN 75MG TABLET / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N014399-005 NORPRAMIN 100MG TABLET / ORAL AB RLD, RS, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N014399-006 NORPRAMIN 150MG TABLET / ORAL AB RLD, Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N014399-007 NORPRAMIN 10MG TABLET / ORAL AB RLD 1982-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N014399-001 NORPRAMIN 25MG TABLET / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N014399-003 NORPRAMIN 50MG TABLET / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N014399-004 NORPRAMIN 75MG TABLET / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N014399-005 NORPRAMIN 100MG TABLET / ORAL AB RLD, RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N014399-006 NORPRAMIN 150MG TABLET / ORAL AB RLD, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N014399-007 NORPRAMIN 10MG TABLET / ORAL AB RLD 1982-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N014399-001 NORPRAMIN 25MG TABLET / ORAL AB RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N014399-003 NORPRAMIN 50MG TABLET / ORAL AB RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N014399-004 NORPRAMIN 75MG TABLET / ORAL AB RLD, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N014399-005 NORPRAMIN 100MG TABLET / ORAL AB RLD, RS, Approved before 1982 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 246 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Norpramin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DESIPRAMINE HYDROCHLORIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1Y58DO4MY1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 12 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1099288 Internal RxNorm lookup 1099290 Internal RxNorm lookup 1099292 Internal RxNorm lookup 1099294 Internal RxNorm lookup 1099296 Internal RxNorm lookup 1099298 Internal RxNorm lookup 1099300 Internal RxNorm lookup 1099302 Internal RxNorm lookup 1099304 Internal RxNorm lookup 1099306 Internal RxNorm lookup 1099316 Internal RxNorm lookup 1099318 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 30698-020-01 Norpramin 100 in 1 BOTTLE TABLET, SUGAR COATED 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 30698-020 NORPRAMIN (DESIPRAMINE HYDROCHLORIDE) TABLET, SUGAR COATED [VALIDUS PHARMACEUTICALS LLC] 5 Current NDC, Legacy NDC, 1 package rows 20231215_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 30698-020-01 30698002001 100 TABLET, SUGAR COATED in 1 BOTTLE (30698-020-01) 1964-11-20 0000-00-00 No No Current