Dronabinol

Product NDC: 63629-8861
11-digit product format: 636298861
Labeler code: 63629
Product ID: 63629-8861_6ef82939-e6ef-4cfa-8084-1c468acc3d38
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dronabinol
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA018651
Marketing category: NDA
Marketing start: 2021-03-03
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

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	63629-8861		D	Discontinued by firm		2026-08-07
excluded package	package	63629-8861	63629-8861-1	D	Discontinued by firm		2026-08-07

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
63629-8861-1	EA - Each	63629-8861	130cdf44-3753-4049-a567-45aa14bcbab6	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8861	DRONABINOL CAPSULE [BRYANT RANCH PREPACK]	102	Legacy NDC	20230316_ad8c4bd7-2ab0-437d-a2dc-4714138ed691.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 · 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
63629-8861-1	63629886101	60 CAPSULE in 1 BOTTLE (63629-8861-1)	60 capsule	2021-09-30	0000-00-00	No	No	Current