Home NDC 0037-6860 Dipentum
Product NDC 0037-6860
11-digit product format 000376860
Labeler code 0037
Product ID 0037-6860_9a4c3abc-74c9-4a2c-a8e3-fc0100d873d9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name olsalazine sodium
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Viatris Specialty LLC
Application NDA019715
Marketing category NDA
Marketing start 2015-05-15
Substance OLSALAZINE SODIUM
Active strength 250 mg/1
Pharmacologic classes Aminosalicylate [EPC], Aminosalicylic Acids [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019715-001 DIPENTUM OLSALAZINE SODIUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019715-001 DIPENTUM 250MG CAPSULE / ORAL RLD, RS 1990-07-31 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Dipentum
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OLSALAZINE SODIUM 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Y7JEW0XG7I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 905162 Internal RxNorm lookup 905164 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0037-6860-10 Dipentum 100 in 1 BOTTLE, PLASTIC CAPSULE, GELATIN COATED 100 15
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0037-6860 DIPENTUM (OLSALAZINE SODIUM) CAPSULE, GELATIN COATED [MEDA PHARMACEUTICALS INC.] 14 Current NDC, Legacy NDC, 1 package rows 20240830_8512d0c6-db4e-4673-b3b4-28975c18413f.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 0037-6860-10 00037686010 100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0037-6860-10) 2015-05-15 0000-00-00 No No Current