Home NDC 0527-4125 DRONABINOL
Product NDC 0527-4125
11-digit product format 005274125
Labeler code 0527
Product ID 0527-4125_aac4561c-b9ba-4d3a-b86c-be120e4593dc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dronabinol
Dosage form CAPSULE
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA207421
Marketing category ANDA
Marketing start 2020-02-10
Substance DRONABINOL
Active strength 2.5 mg/1
Pharmacologic classes Cannabinoid [EPC], Cannabinoids [CS]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0527-4125-35 DRONABINOL 60 in 1 BOTTLE CAPSULE 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-4125 DRONABINOL CAPSULE [LANNETT COMPANY, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20230929_c51d327b-51cc-408d-b0b3-fde5389294d0.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0527-4125-35 00527412535 60 CAPSULE in 1 BOTTLE (0527-4125-35) 60 capsule 2020-02-10 0000-00-00 No No Current