Home NDC 30698-421 EQUETRO
Product NDC 30698-421
11-digit product format 306980421
Labeler code 30698
Product ID 30698-421_3cbb63f0-feee-fc41-e063-6294a90a5d40
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbamazepine
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Validus Pharmaceuticals LLC
Application NDA021710
Marketing category NDA
Marketing start 2004-12-10
Substance CARBAMAZEPINE
Active strength 200 mg/1
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 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 · 14 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 30698-421-12 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 30698-421-12 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 30698-421-12 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 30698-421-12 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 30698-421-12 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 30698-421-12 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 30698-421-12 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021710-001 EQUETRO CARBAMAZEPINE 100MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2004-12-10 N021710-002 EQUETRO CARBAMAZEPINE 200MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2004-12-10 N021710-003 EQUETRO CARBAMAZEPINE 300MG CAPSULE, EXTENDED RELEASE / ORAL RLD, RS 2004-12-10
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 4 of 4 · 129 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 2022-09-29 23:25 UTC 2022-09 N021710-001 EQUETRO 100MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2004-12-10 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021710-002 EQUETRO 200MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2004-12-10 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021710-003 EQUETRO 300MG CAPSULE, EXTENDED RELEASE / ORAL RLD, RS 2004-12-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021710-001 EQUETRO 100MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2004-12-10 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021710-002 EQUETRO 200MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2004-12-10 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021710-003 EQUETRO 300MG CAPSULE, EXTENDED RELEASE / ORAL RLD, RS 2004-12-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021710-001 EQUETRO 100MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2004-12-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021710-002 EQUETRO 200MG CAPSULE, EXTENDED RELEASE / ORAL RLD 2004-12-10 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021710-003 EQUETRO 300MG CAPSULE, EXTENDED RELEASE / ORAL RLD, RS 2004-12-10 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 105 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021710-001 6977253 2024-05-19 U-693 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021710-002 6977253 2024-05-19 U-693 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021710-003 6977253 2024-05-19 U-693 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021710-001 6977253 2024-05-19 U-693 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021710-002 6977253 2024-05-19 U-693 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021710-003 6977253 2024-05-19 U-693 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021710-001 6977253 2024-05-19 U-693 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021710-002 6977253 2024-05-19 U-693 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021710-003 6977253 2024-05-19 U-693 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021710-001 6977253 2024-05-19 U-693 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021710-002 6977253 2024-05-19 U-693 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021710-003 6977253 2024-05-19 U-693 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021710-001 6977253 2024-05-19 U-693 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021710-002 6977253 2024-05-19 U-693 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021710-003 6977253 2024-05-19 U-693 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021710-001 6977253 2024-05-19 U-693 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021710-002 6977253 2024-05-19 U-693 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021710-003 6977253 2024-05-19 U-693 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021710-001 6977253 2024-05-19 U-693 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021710-002 6977253 2024-05-19 U-693 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021710-003 6977253 2024-05-19 U-693 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021710-001 6977253 2024-05-19 U-693 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021710-002 6977253 2024-05-19 U-693 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021710-003 6977253 2024-05-19 U-693 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021710-001 6977253 2024-05-19 U-693 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021710-002 6977253 2024-05-19 U-693 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021710-003 6977253 2024-05-19 U-693 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021710-001 6977253 2024-05-19 U-693 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021710-002 6977253 2024-05-19 U-693 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021710-003 6977253 2024-05-19 U-693 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021710-001 6977253 2024-05-19 U-693 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021710-002 6977253 2024-05-19 U-693 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021710-003 6977253 2024-05-19 U-693 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021710-001 6977253 2024-05-19 U-693 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021710-002 6977253 2024-05-19 U-693 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021710-003 6977253 2024-05-19 U-693 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021710-001 6977253 2024-05-19 U-693 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021710-002 6977253 2024-05-19 U-693 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021710-003 6977253 2024-05-19 U-693 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021710-001 6977253 2024-05-19 U-693 bb7c543d1eb4…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base EQUETRO
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARBAMAZEPINE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 33CM23913M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200131 Internal RxNorm lookup 200133 Internal RxNorm lookup 388311 Internal RxNorm lookup 672908 Internal RxNorm lookup 672909 Internal RxNorm lookup 672910 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 30698-421-12 EQUETRO 120 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 120 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CARBAMAZEPINE ACTIVE INGREDIENT 33CM23913M EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC] 4 CARBAMAZEPINE ACTIVE MOIETY 33CM23913M EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC] 4 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC] 4 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC] 4 GELATIN INACTIVE INGREDIENT 2G86QN327L EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC] 4 POVIDONE INACTIVE INGREDIENT FZ989GH94E EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC] 4 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 30698-421 EQUETRO (CARBAMAZEPINE) CAPSULE, EXTENDED RELEASE [VALIDUS PHARMACEUTICALS LLC] 9 Current NDC, Legacy NDC, 1 package rows 20230113_be478f3c-40f6-47cc-8ab9-f420a9372b1c.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join EQUETRO CARBAMAZEPINE Validus Pharmaceuticals LLC be478f3c-40f6-47cc-8ab9-f420a9372b1c 2025-08-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021710 application number: NDA021710 ndc (product): 30698-421
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 30698-421-12 30698042112 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (30698-421-12) 2004-12-10 0000-00-00 No No Current