Dronabinol

Product NDC
17478-762
11-digit product format
174780762
Labeler code
17478
Product ID
17478-762_2cc92791-29e4-497a-a09b-0786379e5b2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dronabinol
Dosage form
CAPSULE
Route
ORAL
Labeler
Akorn
Application
ANDA079217
Marketing category
ANDA
Marketing start
2014-06-20
Marketing end
0000-00-00
Substance
DRONABINOL
Active strength
5 mg/1
Pharmacologic classes
Cannabinoid [EPC], Cannabinoids [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct17478-762DDiscontinued by firm2026-08-07
excluded packagepackage17478-76217478-762-06DDiscontinued by firm2026-08-07

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 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17478-762-06DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17478-762-06IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17478-762-06IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17478-762-06IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17478-762-06IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17478-762-06IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17478-762-06IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17478-762-06IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17478-762-06IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17478-762-06IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17478-762-06IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17478-762-06IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage17478-762-06IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17478-762-06IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17478-762-06IInactivated by FDA1332a3947898…d4bfe170f9cd…

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
A079217-001DRONABINOLDRONABINOL2.5MGCAPSULE / ORAL2014-06-20
A079217-002DRONABINOLDRONABINOL5MGCAPSULE / ORAL2014-06-20
A079217-003DRONABINOLDRONABINOL10MGCAPSULE / ORAL2014-06-20

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 UTC2026-02A079217-001DRONABINOL2.5MGCAPSULE / ORAL2014-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079217-002DRONABINOL5MGCAPSULE / ORAL2014-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079217-003DRONABINOL10MGCAPSULE / ORAL2014-06-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079217-001DRONABINOL2.5MGCAPSULE / ORAL2014-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079217-002DRONABINOL5MGCAPSULE / ORAL2014-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079217-003DRONABINOL10MGCAPSULE / ORAL2014-06-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A079217-001DRONABINOL2.5MGCAPSULE / ORAL2014-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079217-002DRONABINOL5MGCAPSULE / ORAL2014-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079217-003DRONABINOL10MGCAPSULE / ORAL2014-06-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079217-001DRONABINOL2.5MGCAPSULE / ORAL2014-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079217-002DRONABINOL5MGCAPSULE / ORAL2014-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079217-003DRONABINOL10MGCAPSULE / ORAL2014-06-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079217-001DRONABINOL2.5MGCAPSULE / ORAL2014-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079217-002DRONABINOL5MGCAPSULE / ORAL2014-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079217-003DRONABINOL10MGCAPSULE / ORAL2014-06-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079217-001DRONABINOL2.5MGCAPSULE / ORAL2014-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079217-002DRONABINOL5MGCAPSULE / ORAL2014-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079217-003DRONABINOL10MGCAPSULE / ORAL2014-06-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079217-001DRONABINOL2.5MGCAPSULE / ORAL2014-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079217-002DRONABINOL5MGCAPSULE / ORAL2014-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079217-003DRONABINOL10MGCAPSULE / ORAL2014-06-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079217-001DRONABINOL2.5MGCAPSULE / ORAL2014-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079217-002DRONABINOL5MGCAPSULE / ORAL2014-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079217-003DRONABINOL10MGCAPSULE / ORAL2014-06-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079217-001DRONABINOL2.5MGCAPSULE / ORAL2014-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079217-002DRONABINOL5MGCAPSULE / ORAL2014-06-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079217-003DRONABINOL10MGCAPSULE / ORAL2014-06-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079217-001DRONABINOL2.5MGCAPSULE / ORAL2014-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A079217-002DRONABINOL5MGCAPSULE / ORAL2014-06-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A079217-003DRONABINOL10MGCAPSULE / ORAL2014-06-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079217-001DRONABINOL2.5MGCAPSULE / ORAL2014-06-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079217-002DRONABINOL5MGCAPSULE / ORAL2014-06-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079217-003DRONABINOL10MGCAPSULE / ORAL2014-06-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079217-001DRONABINOL2.5MGCAPSULE / ORAL2014-06-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079217-002DRONABINOL5MGCAPSULE / ORAL2014-06-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079217-003DRONABINOL10MGCAPSULE / ORAL2014-06-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079217-001DRONABINOL2.5MGCAPSULE / ORAL2014-06-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079217-002DRONABINOL5MGCAPSULE / ORAL2014-06-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079217-003DRONABINOL10MGCAPSULE / ORAL2014-06-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079217-001DRONABINOL2.5MGCAPSULE / ORAL2014-06-208072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079217-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079217-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079217-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079217-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A079217-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A079217-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079217-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A079217-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A079217-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079217-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A079217-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A079217-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079217-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A079217-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A079217-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079217-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A079217-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A079217-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079217-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079217-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079217-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A079217-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A079217-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A079217-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079217-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A079217-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A079217-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079217-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A079217-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A079217-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079217-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A079217-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A079217-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A079217-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A079217-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A079217-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A079217-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A079217-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A079217-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079217-001AB16a51e52b5d6a…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a078d9db-810e-ade7-7f79-e8c1623628f9Product name420200617
03fbef77-e64f-4d6b-9d24-bfd1671e5179Product name120190402

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-762-06EA - Each17478-762fa46291f-fe6f-4186-8d4c-59f7bdc8ee9612015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DronabinolACTIVE INGREDIENT7J8897W37SDRONABINOL CAPSULE [AKORN, INC.]2
DronabinolACTIVE MOIETY7J8897W37SDRONABINOL CAPSULE [AKORN, INC.]2
ammoniaINACTIVE INGREDIENT5138Q19F1XDRONABINOL CAPSULE [AKORN, INC.]2
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3DRONABINOL CAPSULE [AKORN, INC.]2
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GDRONABINOL CAPSULE [AKORN, INC.]2
dimethiconeINACTIVE INGREDIENT92RU3N3Y1ODRONABINOL CAPSULE [AKORN, INC.]2
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBDDRONABINOL CAPSULE [AKORN, INC.]2
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOADRONABINOL CAPSULE [AKORN, INC.]2
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A8DRONABINOL CAPSULE [AKORN, INC.]2
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357DRONABINOL CAPSULE [AKORN, INC.]2
gelatinINACTIVE INGREDIENT2G86QN327LDRONABINOL CAPSULE [AKORN, INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXDRONABINOL CAPSULE [AKORN, INC.]2
isopropyl alcoholINACTIVE INGREDIENTND2M416302DRONABINOL CAPSULE [AKORN, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3DRONABINOL CAPSULE [AKORN, INC.]2
sesame oilINACTIVE INGREDIENTQX10HYY4QVDRONABINOL CAPSULE [AKORN, INC.]2
shellacINACTIVE INGREDIENT46N107B71ODRONABINOL CAPSULE [AKORN, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4DRONABINOL CAPSULE [AKORN, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDRONABINOL CAPSULE [AKORN, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RDRONABINOL CAPSULE [AKORN, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-762DRONABINOL CAPSULE [AKORN]6Legacy NDC20220710_a0409d82-a61e-4b9e-8717-ced299ccedb2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17478-762-06174780762061 BOTTLE in 1 CARTON (17478-762-06) > 60 CAPSULE in 1 BOTTLE1 bottle2014-06-200000-00-00NoNoCurrent