Dronabinol

Product NDC: 0527-1450
11-digit product format: 005271450
Labeler code: 0527
Product ID: 0527-1450_87de6548-70dd-4efd-b3c5-8f5a1749e395
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dronabinol
Dosage form: CAPSULE
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA201463
Marketing category: ANDA
Marketing start: 2018-05-18
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: 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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0527-1450		D	Discontinued by firm		2026-08-07
excluded package	package	0527-1450	0527-1450-06	D	Discontinued by firm		2026-08-07

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0527-1450-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0527-1450-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0527-1450-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0527-1450-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0527-1450-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0527-1450-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0527-1450-06	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0527-1450-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0527-1450-06	`0efc9e666f02…`	`f202fb6c5f17…`

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	Approval date
A201463-001	DRONABINOL	DRONABINOL	2.5MG	CAPSULE / ORAL	2018-05-18
A201463-002	DRONABINOL	DRONABINOL	5MG	CAPSULE / ORAL	2018-05-18
A201463-003	DRONABINOL	DRONABINOL	10MG	CAPSULE / ORAL	2018-05-18

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A201463-001	DRONABINOL	2.5MG	CAPSULE / ORAL	2018-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201463-002	DRONABINOL	5MG	CAPSULE / ORAL	2018-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201463-003	DRONABINOL	10MG	CAPSULE / ORAL	2018-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201463-001	DRONABINOL	2.5MG	CAPSULE / ORAL	2018-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201463-002	DRONABINOL	5MG	CAPSULE / ORAL	2018-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201463-003	DRONABINOL	10MG	CAPSULE / ORAL	2018-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201463-001	DRONABINOL	2.5MG	CAPSULE / ORAL	2018-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201463-002	DRONABINOL	5MG	CAPSULE / ORAL	2018-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201463-003	DRONABINOL	10MG	CAPSULE / ORAL	2018-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201463-001	DRONABINOL	2.5MG	CAPSULE / ORAL	2018-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201463-002	DRONABINOL	5MG	CAPSULE / ORAL	2018-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201463-003	DRONABINOL	10MG	CAPSULE / ORAL	2018-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201463-001	DRONABINOL	2.5MG	CAPSULE / ORAL	2018-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201463-002	DRONABINOL	5MG	CAPSULE / ORAL	2018-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201463-003	DRONABINOL	10MG	CAPSULE / ORAL	2018-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201463-001	DRONABINOL	2.5MG	CAPSULE / ORAL	2018-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201463-002	DRONABINOL	5MG	CAPSULE / ORAL	2018-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201463-003	DRONABINOL	10MG	CAPSULE / ORAL	2018-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201463-001	DRONABINOL	2.5MG	CAPSULE / ORAL	2018-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201463-002	DRONABINOL	5MG	CAPSULE / ORAL	2018-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201463-003	DRONABINOL	10MG	CAPSULE / ORAL	2018-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201463-001	DRONABINOL	2.5MG	CAPSULE / ORAL	2018-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201463-002	DRONABINOL	5MG	CAPSULE / ORAL	2018-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201463-003	DRONABINOL	10MG	CAPSULE / ORAL	2018-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201463-001	DRONABINOL	2.5MG	CAPSULE / ORAL	2018-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201463-002	DRONABINOL	5MG	CAPSULE / ORAL	2018-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201463-003	DRONABINOL	10MG	CAPSULE / ORAL	2018-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201463-001	DRONABINOL	2.5MG	CAPSULE / ORAL	2018-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201463-002	DRONABINOL	5MG	CAPSULE / ORAL	2018-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201463-003	DRONABINOL	10MG	CAPSULE / ORAL	2018-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201463-001	DRONABINOL	2.5MG	CAPSULE / ORAL	2018-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201463-002	DRONABINOL	5MG	CAPSULE / ORAL	2018-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201463-003	DRONABINOL	10MG	CAPSULE / ORAL	2018-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201463-001	DRONABINOL	2.5MG	CAPSULE / ORAL	2018-05-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201463-002	DRONABINOL	5MG	CAPSULE / ORAL	2018-05-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201463-003	DRONABINOL	10MG	CAPSULE / ORAL	2018-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201463-001	DRONABINOL	2.5MG	CAPSULE / ORAL	2018-05-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201463-002	DRONABINOL	5MG	CAPSULE / ORAL	2018-05-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201463-003	DRONABINOL	10MG	CAPSULE / ORAL	2018-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201463-001	DRONABINOL	2.5MG	CAPSULE / ORAL	2018-05-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201463-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201463-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201463-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201463-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201463-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201463-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201463-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201463-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201463-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201463-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201463-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201463-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201463-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201463-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201463-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201463-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201463-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A201463-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201463-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201463-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201463-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201463-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201463-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A201463-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201463-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201463-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A201463-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201463-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201463-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A201463-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201463-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201463-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A201463-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201463-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201463-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A201463-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201463-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201463-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A201463-003	AB	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201463-001	AB	1	`3a93d1ddd44b…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0527-1450-06	2024-01-30	C162847	48780-1	1030e365-487b-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use DRONABINOL CAPSULES safely and effectively. See full prescribing information for DRONABINOL CAPSULES. DRONABINOL capsules, for oral use, CIII Initial U.S. Approval: 1985

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-1450-06	EA - Each	0527-1450	07c9dac1-23c2-439c-a5df-1eaa132aa194	1	2018-11-06

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7J8897W37S	DRONABINOL	1972-08-3	DRONABINOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0527-1450-06	00527145006	60 CAPSULE in 1 BOTTLE, PLASTIC (0527-1450-06)	60 capsule	2018-05-18	0000-00-00	No	No	Current