FDA.reportPublic FDA data

DRONABINOL

Product NDC
42858-869
11-digit product format
428580869
Labeler code
42858
Product ID
42858-869_5467a1be-b888-4f7c-9a62-5faf6c977b05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DRONABINOL
Dosage form
CAPSULE
Route
ORAL
Labeler
Rhodes Pharmaceuticals L.P.
Application
ANDA078292
Marketing category
ANDA
Marketing start
2018-06-26
Marketing end
0000-00-00
Substance
DRONABINOL
Active strength
10 mg/1
Pharmacologic classes
Cannabinoid [EPC],Cannabinoids [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42858-869DDiscontinued by firm2026-08-07
excluded packagepackage42858-86942858-869-06DDiscontinued by firm2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078292-001DRONABINOLDRONABINOL2.5MGCAPSULE / ORAL2008-06-27
A078292-002DRONABINOLDRONABINOL5MGCAPSULE / ORAL2008-06-27
A078292-003DRONABINOLDRONABINOL10MGCAPSULE / ORAL2008-06-27

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078292-001DRONABINOL2.5MGCAPSULE / ORAL2008-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078292-002DRONABINOL5MGCAPSULE / ORAL2008-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078292-003DRONABINOL10MGCAPSULE / ORAL2008-06-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078292-001DRONABINOL2.5MGCAPSULE / ORAL2008-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078292-002DRONABINOL5MGCAPSULE / ORAL2008-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078292-003DRONABINOL10MGCAPSULE / ORAL2008-06-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078292-001DRONABINOL2.5MGCAPSULE / ORAL2008-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078292-002DRONABINOL5MGCAPSULE / ORAL2008-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078292-003DRONABINOL10MGCAPSULE / ORAL2008-06-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078292-001DRONABINOL2.5MGCAPSULE / ORAL2008-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078292-002DRONABINOL5MGCAPSULE / ORAL2008-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078292-003DRONABINOL10MGCAPSULE / ORAL2008-06-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078292-001DRONABINOL2.5MGCAPSULE / ORAL2008-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078292-002DRONABINOL5MGCAPSULE / ORAL2008-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078292-003DRONABINOL10MGCAPSULE / ORAL2008-06-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078292-001DRONABINOL2.5MGCAPSULE / ORAL2008-06-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078292-002DRONABINOL5MGCAPSULE / ORAL2008-06-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078292-003DRONABINOL10MGCAPSULE / ORAL2008-06-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078292-001DRONABINOL2.5MGCAPSULE / ORAL2008-06-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078292-002DRONABINOL5MGCAPSULE / ORAL2008-06-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078292-003DRONABINOL10MGCAPSULE / ORAL2008-06-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078292-001DRONABINOL2.5MGCAPSULE / ORAL2008-06-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078292-002DRONABINOL5MGCAPSULE / ORAL2008-06-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078292-003DRONABINOL10MGCAPSULE / ORAL2008-06-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078292-001DRONABINOL2.5MGCAPSULE / ORAL2008-06-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078292-002DRONABINOL5MGCAPSULE / ORAL2008-06-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078292-003DRONABINOL10MGCAPSULE / ORAL2008-06-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078292-001DRONABINOL2.5MGCAPSULE / ORAL2008-06-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078292-002DRONABINOL5MGCAPSULE / ORAL2008-06-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A078292-003DRONABINOL10MGCAPSULE / ORAL2008-06-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078292-001DRONABINOL2.5MGCAPSULE / ORALAB2008-06-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078292-002DRONABINOL5MGCAPSULE / ORALAB2008-06-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078292-003DRONABINOL10MGCAPSULE / ORALAB2008-06-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078292-001DRONABINOL2.5MGCAPSULE / ORALAB2008-06-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078292-002DRONABINOL5MGCAPSULE / ORALAB2008-06-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078292-003DRONABINOL10MGCAPSULE / ORALAB2008-06-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078292-001DRONABINOL2.5MGCAPSULE / ORALAB2008-06-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078292-002DRONABINOL5MGCAPSULE / ORALAB2008-06-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078292-003DRONABINOL10MGCAPSULE / ORALAB2008-06-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078292-001DRONABINOL2.5MGCAPSULE / ORALAB2008-06-278072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078292-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078292-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078292-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078292-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078292-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078292-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078292-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078292-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078292-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078292-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078292-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078292-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078292-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078292-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078292-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078292-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078292-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078292-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078292-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078292-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078292-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078292-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078292-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078292-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078292-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078292-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078292-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078292-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078292-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078292-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078292-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078292-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078292-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A078292-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A078292-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A078292-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078292-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A078292-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A078292-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078292-001AB1c0c555d07b60…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42858-869-06EA - Each42858-869348c10c8-9103-4e33-ba28-ce0489855d4f12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42858-869DRONABINOL CAPSULE [RHODES PHARMACEUTICALS L.P.]5Legacy NDC20230318_3c06ccda-4819-40f8-b2db-fa294bb8a2fa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42858-869-064285808690660 CAPSULE in 1 BOTTLE (42858-869-06) 60 capsule2018-06-260000-00-00NoNoCurrent