Malathion

Product NDC
68022-0001
11-digit product format
680220001
Labeler code
68022
Product ID
68022-0001_dc29a811-fe04-9a2d-e053-2a95a90aa3ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Malathion
Dosage form
LOTION
Route
TOPICAL
Labeler
Suven Pharmaceuticals Limited
Application
ANDA091559
Marketing category
ANDA
Marketing start
2014-02-20
Marketing end
0000-00-00
Substance
MALATHION
Active strength
0 g/mL
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
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 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091559-001MALATHIONMALATHION0.5%LOTION / TOPICALRS2012-05-23

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-233f01610625f2…
2019-09-15 20:21 UTC2019-09A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-23b00525d2431f…
2019-07-19 19:46 UTC2019-07A091559-001MALATHION0.5%LOTION / TOPICALAT2012-05-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091559-001MALATHION0.5%LOTION / TOPICALRS2012-05-23e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07A091559-001AT1ea99ee380514…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MALATHIONACTIVE INGREDIENTU5N7SU872WMALATHION LOTION [SUVEN LIFE SCIENCES LIMITED]2
MALATHIONACTIVE MOIETYU5N7SU872WMALATHION LOTION [SUVEN LIFE SCIENCES LIMITED]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302MALATHION LOTION [SUVEN LIFE SCIENCES LIMITED]2
LIMONENE, (+/-)-INACTIVE INGREDIENT9MC3I34447MALATHION LOTION [SUVEN LIFE SCIENCES LIMITED]2
PINE NEEDLE OIL (PINUS SYLVESTRIS)INACTIVE INGREDIENT5EXL5H740YMALATHION LOTION [SUVEN LIFE SCIENCES LIMITED]2
TERPINEOLINACTIVE INGREDIENTR53Q4ZWC99MALATHION LOTION [SUVEN LIFE SCIENCES LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68022-0001MALATHION LOTION [SUVEN PHARMACEUTICALS LIMITED]6Legacy NDC20240110_d792c1cb-ec9b-4942-8096-101d01293cea.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OvideMALATHIONSun Pharmaceutical Industries, Inc.945f46fa-4b79-49fd-a890-477f251e21642026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091559
application number: ANDA091559
MalathionMALATHIONSun Pharmaceutical Industries, Inc.a0b1444b-f51b-44fd-8f23-2fff49b64bc02026-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091559
application number: ANDA091559

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68022-0001-1680220001011 BOTTLE in 1 CARTON (68022-0001-1) > 59 mL in 1 BOTTLE1 bottle2014-03-040000-00-00NoNoCurrent