Marinol

Product NDC: 0051-0023
11-digit product format: 000510023
Labeler code: 0051
Product ID: 0051-0023_b35d3e84-6f3c-f566-ee76-691936f050c2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dronabinol
Dosage form: CAPSULE
Route: ORAL
Labeler: AbbVie Inc.
Application: NDA018651
Marketing category: NDA
Marketing start: 2010-07-13
Marketing end: 2021-03-31
Substance: DRONABINOL
Active strength: 10 mg/1
Pharmacologic classes: Cannabinoid [EPC],Cannabinoids [CS]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 0000-00-00
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	0051-0023		D	Discontinued by firm		2026-08-07
excluded package	package	0051-0023	0051-0023-21	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 · 24 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	0051-0023-21	`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	0051-0023-21	`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	0051-0023-21	`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	0051-0023-21	`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	0051-0023-21	`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	0051-0023-21	`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	0051-0023-21	`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	0051-0023-21	`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	0051-0023-21	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0051-0023-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0051-0023-21	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0051-0023-21	`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
N018651-001	MARINOL	DRONABINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31
N018651-002	MARINOL	DRONABINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31
N018651-003	MARINOL	DRONABINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N018651-001	AB
N018651-002	AB
N018651-003	AB

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	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018651-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018651-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018651-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018651-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018651-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018651-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018651-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018651-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018651-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018651-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018651-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018651-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018651-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018651-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018651-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018651-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018651-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018651-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018651-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018651-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018651-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018651-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018651-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018651-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018651-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018651-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018651-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018651-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018651-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018651-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018651-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018651-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018651-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018651-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018651-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018651-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018651-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018651-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018651-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018651-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0051-0023-21	EA - Each	0051-0023	38a99f7b-ea24-4be5-8fa2-77fb2921db17	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
dronabinol	ACTIVE INGREDIENT	7J8897W37S	MARINOL (DRONABINOL) CAPSULE [ABBVIE INC.]	16
dronabinol	ACTIVE MOIETY	7J8897W37S	MARINOL (DRONABINOL) CAPSULE [ABBVIE INC.]	16
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	MARINOL (DRONABINOL) CAPSULE [ABBVIE INC.]	16
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	MARINOL (DRONABINOL) CAPSULE [ABBVIE INC.]	16
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	MARINOL (DRONABINOL) CAPSULE [ABBVIE INC.]	16
gelatin	INACTIVE INGREDIENT	2G86QN327L	MARINOL (DRONABINOL) CAPSULE [ABBVIE INC.]	16
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	MARINOL (DRONABINOL) CAPSULE [ABBVIE INC.]	16
sesame oil	INACTIVE INGREDIENT	QX10HYY4QV	MARINOL (DRONABINOL) CAPSULE [ABBVIE INC.]	16
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	MARINOL (DRONABINOL) CAPSULE [ABBVIE INC.]	16

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dronabinol	DRONABINOL	Major Pharmaceuticals	fd8c5d57-0173-4f62-8ff0-d8147986a976	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018651 application number: NDA018651
Dronabinol	DRONABINOL	Ascend Laboratories, LLC	adb1801c-0fb5-4e16-b969-1db91230e0b9	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018651 application number: NDA018651
MARINOL	DRONABINOL	ThePharmaNetwork, LLC	d0efeeec-640d-43c3-8f0a-d31324a11c68	2023-02-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018651 application number: NDA018651
Marinol	DRONABINOL	ThePharmaNetwork, LLC	628f9609-6583-49be-be77-b64cfbc46fd7	2019-04-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018651 application number: NDA018651

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
0051-0023-21	00051002321	1 BOTTLE in 1 CARTON (0051-0023-21) > 60 CAPSULE in 1 BOTTLE	1 bottle	2010-07-13	2021-03-31	No	No	Current