MARINOL

Product NDC: 53097-571
Requested package NDC: 53097-571-60
11-digit product format: 530970571
Labeler code: 53097
Product ID: 53097-571_5ce802d5-e8ab-4cd1-9ba0-1f39f22ddd48
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dronabinol
Dosage form: CAPSULE
Route: ORAL
Labeler: ThePharmaNetwork, LLC
Application: NDA018651
Marketing category: NDA
Marketing start: 2021-03-03
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

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53097-571	53097-571-60	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 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
2026-09-14 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…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N018651-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018651-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018651-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018651-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018651-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018651-003	AB	1	`caaa826d4ba7…`
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…`

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: MARINOL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DRONABINOL	2.5 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197634	Internal RxNorm lookup
197635	Internal RxNorm lookup
197636	Internal RxNorm lookup
205641	Internal RxNorm lookup
205642	Internal RxNorm lookup
205645	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
d0efeeec-640d-43c3-8f0a-d31324a11c68	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
53097-571-60	MARINOL	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
53097-571-60	EA - Each	53097-571	d0de4a94-e857-434f-a737-6f4f18f8e15a	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53097-571	MARINOL (DRONABINOL) CAPSULE [THEPHARMANETWORK, LLC]	5	Current NDC, Legacy NDC, 1 package rows	20230215_d0efeeec-640d-43c3-8f0a-d31324a11c68.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 ndc (package): 53097-571-60 ndc (product): 53097-571 ndc11 (package): 53097057160
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
197634	droNABinol 10 MG Oral Capsule	PSN	d0efeeec-640d-43c3-8f0a-d31324a11c68	5
197635	droNABinol 2.5 MG Oral Capsule	PSN	d0efeeec-640d-43c3-8f0a-d31324a11c68	5
197636	droNABinol 5 MG Oral Capsule	PSN	d0efeeec-640d-43c3-8f0a-d31324a11c68	5
205645	Marinol 10 MG Oral Capsule	PSN	d0efeeec-640d-43c3-8f0a-d31324a11c68	5
205641	Marinol 2.5 MG Oral Capsule	PSN	d0efeeec-640d-43c3-8f0a-d31324a11c68	5
205642	Marinol 5 MG Oral Capsule	PSN	d0efeeec-640d-43c3-8f0a-d31324a11c68	5
205645	dronabinol 10 MG Oral Capsule [Marinol]	SBD	d0efeeec-640d-43c3-8f0a-d31324a11c68	5
205641	dronabinol 2.5 MG Oral Capsule [Marinol]	SBD	d0efeeec-640d-43c3-8f0a-d31324a11c68	5
205642	dronabinol 5 MG Oral Capsule [Marinol]	SBD	d0efeeec-640d-43c3-8f0a-d31324a11c68	5
197634	dronabinol 10 MG Oral Capsule	SCD	d0efeeec-640d-43c3-8f0a-d31324a11c68	5
197635	dronabinol 2.5 MG Oral Capsule	SCD	d0efeeec-640d-43c3-8f0a-d31324a11c68	5
197636	dronabinol 5 MG Oral Capsule	SCD	d0efeeec-640d-43c3-8f0a-d31324a11c68	5
197634	dronabinol 10 MG Oral Capsule	SY	d0efeeec-640d-43c3-8f0a-d31324a11c68	5
205645	dronabinol 10 MG Oral Capsule [Marinol]	SY	d0efeeec-640d-43c3-8f0a-d31324a11c68	5
197635	dronabinol 2.5 MG Oral Capsule	SY	d0efeeec-640d-43c3-8f0a-d31324a11c68	5
205641	dronabinol 2.5 MG Oral Capsule [Marinol]	SY	d0efeeec-640d-43c3-8f0a-d31324a11c68	5
197636	dronabinol 5 MG Oral Capsule	SY	d0efeeec-640d-43c3-8f0a-d31324a11c68	5
205642	dronabinol 5 MG Oral Capsule [Marinol]	SY	d0efeeec-640d-43c3-8f0a-d31324a11c68	5
205645	Marinol 10 MG Oral Capsule	SY	d0efeeec-640d-43c3-8f0a-d31324a11c68	5
205641	Marinol 2.5 MG Oral Capsule	SY	d0efeeec-640d-43c3-8f0a-d31324a11c68	5
205642	Marinol 5 MG Oral Capsule	SY	d0efeeec-640d-43c3-8f0a-d31324a11c68	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53097-571-60	53097057160	60 CAPSULE in 1 BOTTLE (53097-571-60)	60 capsule	2021-03-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MARINOL	ThePharmaNetwork, LLC \| Patheon Softgels Inc \| Mikart, LLC \| Apace Packaging LLC \| Nutra-Med Packaging Inc.	2023-02-14	Human Prescription Drug Label	5