Home NDC 42291-234-01 Disopyramide Phosphate
Product NDC 42291-234
Requested package NDC 42291-234-01
11-digit product format 422910234
Labeler code 42291
Product ID 42291-234_d579fa0e-c033-3005-e053-2995a90af9a8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Disopyramide Phosphate
Dosage form CAPSULE
Route ORAL
Labeler AvKARE
Application ANDA070101
Marketing category ANDA
Marketing start 2014-01-03
Marketing end 0000-00-00
Substance DISOPYRAMIDE PHOSPHATE
Active strength 100 mg/1
Pharmacologic classes Antiarrhythmic [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A070101-001 DISOPYRAMIDE PHOSPHATE DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A070101-001 AB
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 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A070101-001 DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE / ORAL AB 1985-02-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DISOPYRAMIDE PHOSPHATE ACTIVE INGREDIENT N6BOM1935W DISOPYRAMIDE PHOSPHATE (DISOPYRAMIDE PHOSPHATE) CAPSULE [AVKARE, INC.] 4 DISOPYRAMIDE ACTIVE MOIETY GFO928U8MQ DISOPYRAMIDE PHOSPHATE (DISOPYRAMIDE PHOSPHATE) CAPSULE [AVKARE, INC.] 4 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 DISOPYRAMIDE PHOSPHATE (DISOPYRAMIDE PHOSPHATE) CAPSULE [AVKARE, INC.] 4 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH DISOPYRAMIDE PHOSPHATE (DISOPYRAMIDE PHOSPHATE) CAPSULE [AVKARE, INC.] 4 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L DISOPYRAMIDE PHOSPHATE (DISOPYRAMIDE PHOSPHATE) CAPSULE [AVKARE, INC.] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G DISOPYRAMIDE PHOSPHATE (DISOPYRAMIDE PHOSPHATE) CAPSULE [AVKARE, INC.] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD DISOPYRAMIDE PHOSPHATE (DISOPYRAMIDE PHOSPHATE) CAPSULE [AVKARE, INC.] 4 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK DISOPYRAMIDE PHOSPHATE (DISOPYRAMIDE PHOSPHATE) CAPSULE [AVKARE, INC.] 4 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA DISOPYRAMIDE PHOSPHATE (DISOPYRAMIDE PHOSPHATE) CAPSULE [AVKARE, INC.] 4 GELATIN INACTIVE INGREDIENT 2G86QN327L DISOPYRAMIDE PHOSPHATE (DISOPYRAMIDE PHOSPHATE) CAPSULE [AVKARE, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DISOPYRAMIDE PHOSPHATE (DISOPYRAMIDE PHOSPHATE) CAPSULE [AVKARE, INC.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DISOPYRAMIDE PHOSPHATE (DISOPYRAMIDE PHOSPHATE) CAPSULE [AVKARE, INC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DISOPYRAMIDE PHOSPHATE (DISOPYRAMIDE PHOSPHATE) CAPSULE [AVKARE, INC.] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J DISOPYRAMIDE PHOSPHATE (DISOPYRAMIDE PHOSPHATE) CAPSULE [AVKARE, INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DISOPYRAMIDE PHOSPHATE (DISOPYRAMIDE PHOSPHATE) CAPSULE [AVKARE, INC.] 4
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-234-01 42291023401 100 CAPSULE in 1 BOTTLE (42291-234-01) 100 capsule 2014-01-03 0000-00-00 No No Current