Home NDC 67386-621-52 CARNEXIV
Product NDC 67386-621
Requested package NDC 67386-621-52
11-digit product format 673860621
Labeler code 67386
Product ID 67386-621_d4a2d8e6-a918-4cfe-a9cf-195ab73c7587
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbamazepine
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Lundbeck Pharmaceuticals LLC
Application NDA206030
Marketing category NDA
Marketing start 2014-10-21
Marketing end 0000-00-00
Substance CARBAMAZEPINE
Active strength 10 mg/mL
Pharmacologic classes Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 N206030-001 CARNEXIV CARBAMAZEPINE 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2016-10-07
Orange Book patents# Current patent rows page 1 of 1 · 9 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206030-001 9629797 2028-11-10 U-2004 2017-05-10 N206030-001 9629797 2028-11-10 U-2005 2017-05-10 N206030-001 9629797 2028-11-10 U-2006 2017-05-10 N206030-001 9770407 2028-11-10 Drug product 2017-10-04 N206030-001 7635773 2029-03-13 Drug product 2016-10-18 N206030-001 8410077 2029-03-13 Drug product 2016-10-18 N206030-001 9750822 2029-03-13 Drug product 2017-10-27 N206030-001 9493582 2033-02-27 Drug product 2016-12-08 N206030-001 11529357 2040-01-31 Drug product 2023-01-17
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.
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 2026-08-01 22:54:32 2026-06 N206030-001 CARNEXIV 200MG/20ML (10MG/ML) SOLUTION / INTRAVENOUS RLD 2016-10-07 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N206030-001 9629797 2028-11-10 U-2004 2017-05-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N206030-001 9629797 2028-11-10 U-2005 2017-05-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N206030-001 9629797 2028-11-10 U-2006 2017-05-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N206030-001 9770407 2028-11-10 Drug product 2017-10-04 a50c72e98297…2026-08-01 22:54:32 2026-06 N206030-001 7635773 2029-03-13 Drug product 2016-10-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N206030-001 8410077 2029-03-13 Drug product 2016-10-18 a50c72e98297…2026-08-01 22:54:32 2026-06 N206030-001 9750822 2029-03-13 Drug product 2017-10-27 a50c72e98297…2026-08-01 22:54:32 2026-06 N206030-001 9493582 2033-02-27 Drug product 2016-12-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N206030-001 11529357 2040-01-31 Drug product 2023-01-17 a50c72e98297…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67386-621-52 67386062152 1 VIAL, GLASS in 1 CARTON (67386-621-52) > 20 mL in 1 VIAL, GLASS 2014-10-21 0000-00-00 No No Current