Home NDC 42291-449-60 DRONABINOL
Product NDC 42291-449
Requested package NDC 42291-449-60
11-digit product format 422910449
Labeler code 42291
Product ID 42291-449_77794c6c-82e4-43d1-8126-b0776d80fa17
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dronabinol
Dosage form CAPSULE
Route ORAL
Labeler AvKARE
Application ANDA207421
Marketing category ANDA
Marketing start 2020-03-16
Marketing end 0000-00-00
Substance DRONABINOL
Active strength 3 mg/1
Pharmacologic classes Cannabinoid [EPC],Cannabinoids [CS]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2021-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A207421-001 DRONABINOL DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 A207421-002 DRONABINOL DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 A207421-003 DRONABINOL DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 3 · 111 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 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207421-002 DRONABINOL 5MG CAPSULE / ORAL AB 2020-02-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207421-003 DRONABINOL 10MG CAPSULE / ORAL AB 2020-02-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207421-001 DRONABINOL 2.5MG CAPSULE / ORAL AB 2020-02-07 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-449-60 42291044960 60 CAPSULE in 1 BOTTLE (42291-449-60) 60 capsule 2020-03-16 0000-00-00 No No Current