Home NDC 17478-762 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 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 date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 17478-762-06 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 17478-762-06 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 17478-762-06 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 17478-762-06 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 17478-762-06 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 17478-762-06 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 17478-762-06 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 17478-762-06 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 17478-762-06 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 17478-762-06 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 17478-762-06 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 17478-762-06 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 17478-762-06 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 17478-762-06 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17478-762-06 I Inactivated by FDA 1332a3947898…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079217-001 DRONABINOL DRONABINOL 2.5MG CAPSULE / ORAL 2014-06-20 A079217-002 DRONABINOL DRONABINOL 5MG CAPSULE / ORAL 2014-06-20 A079217-003 DRONABINOL DRONABINOL 10MG CAPSULE / ORAL 2014-06-20
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 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 A079217-001 DRONABINOL 2.5MG CAPSULE / ORAL 2014-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079217-002 DRONABINOL 5MG CAPSULE / ORAL 2014-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079217-003 DRONABINOL 10MG CAPSULE / ORAL 2014-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079217-001 DRONABINOL 2.5MG CAPSULE / ORAL 2014-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079217-002 DRONABINOL 5MG CAPSULE / ORAL 2014-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079217-003 DRONABINOL 10MG CAPSULE / ORAL 2014-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079217-001 DRONABINOL 2.5MG CAPSULE / ORAL 2014-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079217-002 DRONABINOL 5MG CAPSULE / ORAL 2014-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079217-003 DRONABINOL 10MG CAPSULE / ORAL 2014-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079217-001 DRONABINOL 2.5MG CAPSULE / ORAL 2014-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079217-002 DRONABINOL 5MG CAPSULE / ORAL 2014-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079217-003 DRONABINOL 10MG CAPSULE / ORAL 2014-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079217-001 DRONABINOL 2.5MG CAPSULE / ORAL 2014-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079217-002 DRONABINOL 5MG CAPSULE / ORAL 2014-06-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079217-003 DRONABINOL 10MG CAPSULE / ORAL 2014-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079217-001 DRONABINOL 2.5MG CAPSULE / ORAL 2014-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079217-002 DRONABINOL 5MG CAPSULE / ORAL 2014-06-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079217-003 DRONABINOL 10MG CAPSULE / ORAL 2014-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079217-001 DRONABINOL 2.5MG CAPSULE / ORAL 2014-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079217-002 DRONABINOL 5MG CAPSULE / ORAL 2014-06-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079217-003 DRONABINOL 10MG CAPSULE / ORAL 2014-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079217-001 DRONABINOL 2.5MG CAPSULE / ORAL 2014-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079217-002 DRONABINOL 5MG CAPSULE / ORAL 2014-06-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079217-003 DRONABINOL 10MG CAPSULE / ORAL 2014-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079217-001 DRONABINOL 2.5MG CAPSULE / ORAL 2014-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079217-002 DRONABINOL 5MG CAPSULE / ORAL 2014-06-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079217-003 DRONABINOL 10MG CAPSULE / ORAL 2014-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079217-001 DRONABINOL 2.5MG CAPSULE / ORAL 2014-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079217-002 DRONABINOL 5MG CAPSULE / ORAL 2014-06-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A079217-003 DRONABINOL 10MG CAPSULE / ORAL 2014-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079217-001 DRONABINOL 2.5MG CAPSULE / ORAL 2014-06-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079217-002 DRONABINOL 5MG CAPSULE / ORAL 2014-06-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079217-003 DRONABINOL 10MG CAPSULE / ORAL 2014-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079217-001 DRONABINOL 2.5MG CAPSULE / ORAL 2014-06-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079217-002 DRONABINOL 5MG CAPSULE / ORAL 2014-06-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079217-003 DRONABINOL 10MG CAPSULE / ORAL 2014-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079217-001 DRONABINOL 2.5MG CAPSULE / ORAL 2014-06-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079217-002 DRONABINOL 5MG CAPSULE / ORAL 2014-06-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079217-003 DRONABINOL 10MG CAPSULE / ORAL 2014-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079217-001 DRONABINOL 2.5MG CAPSULE / ORAL 2014-06-20 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Dronabinol ACTIVE INGREDIENT 7J8897W37S DRONABINOL CAPSULE [AKORN, INC.] 2 Dronabinol ACTIVE MOIETY 7J8897W37S DRONABINOL CAPSULE [AKORN, INC.] 2 ammonia INACTIVE INGREDIENT 5138Q19F1X DRONABINOL CAPSULE [AKORN, INC.] 2 butyl alcohol INACTIVE INGREDIENT 8PJ61P6TS3 DRONABINOL CAPSULE [AKORN, INC.] 2 D&C yellow no. 10 INACTIVE INGREDIENT 35SW5USQ3G DRONABINOL CAPSULE [AKORN, INC.] 2 dimethicone INACTIVE INGREDIENT 92RU3N3Y1O DRONABINOL CAPSULE [AKORN, INC.] 2 FD&C blue no. 1 INACTIVE INGREDIENT H3R47K3TBD DRONABINOL CAPSULE [AKORN, INC.] 2 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA DRONABINOL CAPSULE [AKORN, INC.] 2 FD&C yellow no. 6 INACTIVE INGREDIENT H77VEI93A8 DRONABINOL CAPSULE [AKORN, INC.] 2 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 DRONABINOL CAPSULE [AKORN, INC.] 2 gelatin INACTIVE INGREDIENT 2G86QN327L DRONABINOL CAPSULE [AKORN, INC.] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX DRONABINOL CAPSULE [AKORN, INC.] 2 isopropyl alcohol INACTIVE INGREDIENT ND2M416302 DRONABINOL CAPSULE [AKORN, INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 DRONABINOL CAPSULE [AKORN, INC.] 2 sesame oil INACTIVE INGREDIENT QX10HYY4QV DRONABINOL CAPSULE [AKORN, INC.] 2 shellac INACTIVE INGREDIENT 46N107B71O DRONABINOL CAPSULE [AKORN, INC.] 2 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 DRONABINOL CAPSULE [AKORN, INC.] 2 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP DRONABINOL CAPSULE [AKORN, INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R DRONABINOL CAPSULE [AKORN, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17478-762 DRONABINOL CAPSULE [AKORN] 6 Legacy NDC 20220710_a0409d82-a61e-4b9e-8717-ced299ccedb2.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 17478-762-06 17478076206 1 BOTTLE in 1 CARTON (17478-762-06) > 60 CAPSULE in 1 BOTTLE 1 bottle 2014-06-20 0000-00-00 No No Current