Dronabinol

Product NDC: 67877-754
11-digit product format: 678770754
Labeler code: 67877
Product ID: 67877-754_97b6c4dc-59b5-4ee6-b296-26ccdf9ef853
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dronabinol
Dosage form: CAPSULE
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: NDA018651
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2021-03-03
Substance: DRONABINOL
Active strength: 5 mg/1
Pharmacologic classes: Cannabinoid [EPC], Cannabinoids [CS]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 132 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
2026-10-15 13:18:30	2026-09	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018651-001	MARINOL	2.5MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018651-002	MARINOL	5MG	CAPSULE / ORAL	AB	RLD, RS	1985-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018651-003	MARINOL	10MG	CAPSULE / ORAL	AB	RLD	1985-05-31	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	N018651-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018651-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018651-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018651-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018651-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018651-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018651-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018651-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018651-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018651-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018651-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018651-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018651-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018651-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N018651-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N018651-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018651-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N018651-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N018651-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018651-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018651-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018651-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018651-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018651-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018651-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018651-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018651-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018651-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018651-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018651-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018651-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018651-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N018651-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N018651-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018651-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N018651-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N018651-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018651-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018651-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018651-003	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Dronabinol
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DRONABINOL	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7J8897W37S	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197634	Internal RxNorm lookup
197635	Internal RxNorm lookup
197636	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
adb1801c-0fb5-4e16-b969-1db91230e0b9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a078d9db-810e-ade7-7f79-e8c1623628f9	Product name	4	20200617
03fbef77-e64f-4d6b-9d24-bfd1671e5179	Product name	1	20190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67877-754-60	Dronabinol	60 in 1 BOTTLE	CAPSULE	60		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-754-60	EA - Each	67877-754	dad8f9b3-e13c-4c9e-b960-c6b648ddff60	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-754	DRONABINOL CAPSULE [ASCEND LABORATORIES, LLC]	4	Current NDC, Legacy NDC, 1 package rows	20230121_adb1801c-0fb5-4e16-b969-1db91230e0b9.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 ndc (product): 67877-754
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197635	droNABinol 2.5 MG Oral Capsule	PSN	fd8c5d57-0173-4f62-8ff0-d8147986a976	6
197636	droNABinol 5 MG Oral Capsule	PSN	fd8c5d57-0173-4f62-8ff0-d8147986a976	6
197635	dronabinol 2.5 MG Oral Capsule	SCD	fd8c5d57-0173-4f62-8ff0-d8147986a976	6
197636	dronabinol 5 MG Oral Capsule	SCD	fd8c5d57-0173-4f62-8ff0-d8147986a976	6
197635	dronabinol 2.5 MG Oral Capsule	SY	fd8c5d57-0173-4f62-8ff0-d8147986a976	6
197636	dronabinol 5 MG Oral Capsule	SY	fd8c5d57-0173-4f62-8ff0-d8147986a976	6
197634	droNABinol 10 MG Oral Capsule	PSN	adb1801c-0fb5-4e16-b969-1db91230e0b9	5
197635	droNABinol 2.5 MG Oral Capsule	PSN	adb1801c-0fb5-4e16-b969-1db91230e0b9	5
197636	droNABinol 5 MG Oral Capsule	PSN	adb1801c-0fb5-4e16-b969-1db91230e0b9	5
197634	dronabinol 10 MG Oral Capsule	SCD	adb1801c-0fb5-4e16-b969-1db91230e0b9	5
197635	dronabinol 2.5 MG Oral Capsule	SCD	adb1801c-0fb5-4e16-b969-1db91230e0b9	5
197636	dronabinol 5 MG Oral Capsule	SCD	adb1801c-0fb5-4e16-b969-1db91230e0b9	5
197634	dronabinol 10 MG Oral Capsule	SY	adb1801c-0fb5-4e16-b969-1db91230e0b9	5
197635	dronabinol 2.5 MG Oral Capsule	SY	adb1801c-0fb5-4e16-b969-1db91230e0b9	5
197636	dronabinol 5 MG Oral Capsule	SY	adb1801c-0fb5-4e16-b969-1db91230e0b9	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-754-60	67877075460	60 CAPSULE in 1 BOTTLE (67877-754-60)	60 capsule	2021-03-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dronabinol	Major Pharmaceuticals	2026-05-13	HUMAN PRESCRIPTION DRUG LABEL	6
Dronabinol	Ascend Laboratories, LLC \| Patheon Softgels Inc \| Apace Packaging LLC \| Nutra-Med Packaging Inc.	2026-05-06	Human Prescription Drug Label	5
Dronabinol	Bryant Ranch Prepack	2023-03-30	HUMAN PRESCRIPTION DRUG LABEL	100
Dronabinol	Bryant Ranch Prepack	2023-03-15	HUMAN PRESCRIPTION DRUG LABEL	102