Home NDC 68418-7941 Diacomit
Product NDC 68418-7941
11-digit product format 684187941
Labeler code 68418
Product ID 68418-7941_7c968964-991e-4ec2-bc03-ef062b5bb0f9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name stiripentol
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler BIOCODEX, INC.
Application NDA207223
Marketing category NDA
Marketing start 2018-08-21
Substance STIRIPENTOL
Active strength 250 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68418-7941-6 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68418-7941-6 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68418-7941-6 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N207223-001 DIACOMIT STIRIPENTOL 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 N207223-002 DIACOMIT STIRIPENTOL 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N207223-001 ODE-403 2029-07-14 N207223-002 ODE-403 2029-07-14
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 3 · 82 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 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N207223-001 DIACOMIT 250MG/PACKET FOR SUSPENSION / ORAL RLD 2018-08-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N207223-002 DIACOMIT 500MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2018-08-20 782e0a99824c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 216 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Diacomit
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength STIRIPENTOL 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R02XOT8V8I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2054973 Internal RxNorm lookup 2054979 Internal RxNorm lookup 2054981 Internal RxNorm lookup 2054983 Internal RxNorm lookup 2055011 Internal RxNorm lookup 2055014 Internal RxNorm lookup 2055015 Internal RxNorm lookup 2055016 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 68418-7941-6 Diacomit 60 in 1 CARTON POWDER, FOR SUSPENSION 60 8 68418-7941-6 Diacomit 1 in 1 PACKET POWDER, FOR SUSPENSION 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68418-7941 DIACOMIT (STIRIPENTOL) CAPSULE DIACOMIT (STIRIPENTOL) POWDER, FOR SUSPENSION [BIOCODEX, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20240608_58304ba8-9779-4658-811e-94ffe08c3f16.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 Units Marketing start Marketing end Sample Exclude flag Status 68418-7941-6 68418794106 60 PACKET in 1 CARTON (68418-7941-6) / 1 POWDER, FOR SUSPENSION in 1 PACKET 60 packet 2018-08-21 0000-00-00 No No Current