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 firm2026-10-15
excluded packagepackage42858-86942858-869-06DDiscontinued by firm2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A078292-001DRONABINOL2.5MGCAPSULE / ORAL2008-06-27c2088c7a36db…
2026-10-15 13:18:302026-09A078292-002DRONABINOL5MGCAPSULE / ORAL2008-06-27c2088c7a36db…
2026-10-15 13:18:302026-09A078292-003DRONABINOL10MGCAPSULE / ORAL2008-06-27c2088c7a36db…
2026-09-14 22:38:342026-08A078292-001DRONABINOL2.5MGCAPSULE / ORAL2008-06-2784e616aacf4f…
2026-09-14 22:38:342026-08A078292-002DRONABINOL5MGCAPSULE / ORAL2008-06-2784e616aacf4f…
2026-09-14 22:38:342026-08A078292-003DRONABINOL10MGCAPSULE / ORAL2008-06-2784e616aacf4f…
2026-08-18 06:07:402026-07A078292-001DRONABINOL2.5MGCAPSULE / ORAL2008-06-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078292-002DRONABINOL5MGCAPSULE / ORAL2008-06-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078292-003DRONABINOL10MGCAPSULE / ORAL2008-06-27caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 90 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2020-11-12 02:37 UTC2020-11A078292-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A078292-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078292-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A078292-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A078292-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A078292-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078292-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078292-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078292-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A078292-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A078292-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078292-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078292-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078292-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078292-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A078292-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A078292-003AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078292-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A078292-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A078292-003AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078292-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078292-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078292-003AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078292-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078292-002AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078292-003AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078292-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078292-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078292-003AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078292-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078292-002AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078292-003AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078292-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A078292-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A078292-003AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078292-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A078292-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A078292-003AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078292-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078292-002AB13a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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