SYNDROS

Product NDC: 78613-201
11-digit product format: 786130201
Labeler code: 78613
Product ID: 78613-201_3e1cbbb1-291c-41bb-b209-93c1fb08313a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dronabinol
Dosage form: SOLUTION
Route: ORAL
Labeler: Benuvia Operations, LLC
Application: NDA205525
Marketing category: NDA
Marketing start: 2017-07-01
Marketing end: 2027-04-30
Substance: DRONABINOL
Active strength: 5 mg/mL
Pharmacologic classes: Cannabinoid [EPC], Cannabinoids [CS]
DEA schedule: CII
NDC exclude flag: No
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205525-001	SYNDROS	DRONABINOL	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2017-03-23

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N205525-001	10265293	2028-08-06	Drug substance, Drug product	2019-05-23
N205525-001	11253472	2028-08-06	Drug substance, Drug product	2022-03-08
N205525-001	8222292	2028-08-06	Drug substance, Drug product	2017-03-30
N205525-001	9345771	2028-08-06	Drug substance, Drug product	2017-03-30

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205525-001	SYNDROS	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205525-001	SYNDROS	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205525-001	SYNDROS	5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2017-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD	2017-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD	2017-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD	2017-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD	2017-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD	2017-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD	2017-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD	2017-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205525-001	SYNDROS	5MG/ML	SOLUTION / ORAL	RLD, RS	2017-03-23	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 154 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205525-001	10265293	2028-08-06	Drug substance, Drug product	2019-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205525-001	11253472	2028-08-06	Drug substance, Drug product	2022-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205525-001	8222292	2028-08-06	Drug substance, Drug product	2017-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205525-001	9345771	2028-08-06	Drug substance, Drug product	2017-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205525-001	10265293	2028-08-06	Drug substance, Drug product	2019-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205525-001	11253472	2028-08-06	Drug substance, Drug product	2022-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205525-001	8222292	2028-08-06	Drug substance, Drug product	2017-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205525-001	9345771	2028-08-06	Drug substance, Drug product	2017-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205525-001	10265293	2028-08-06	Drug substance, Drug product	2019-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205525-001	11253472	2028-08-06	Drug substance, Drug product	2022-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205525-001	8222292	2028-08-06	Drug substance, Drug product	2017-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205525-001	9345771	2028-08-06	Drug substance, Drug product	2017-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205525-001	10265293	2028-08-06	Drug substance, Drug product	2019-05-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205525-001	11253472	2028-08-06	Drug substance, Drug product	2022-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205525-001	8222292	2028-08-06	Drug substance, Drug product	2017-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205525-001	9345771	2028-08-06	Drug substance, Drug product	2017-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205525-001	10265293	2028-08-06	Drug substance, Drug product	2019-05-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205525-001	11253472	2028-08-06	Drug substance, Drug product	2022-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205525-001	8222292	2028-08-06	Drug substance, Drug product	2017-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205525-001	9345771	2028-08-06	Drug substance, Drug product	2017-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205525-001	10265293	2028-08-06	Drug substance, Drug product	2019-05-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205525-001	11253472	2028-08-06	Drug substance, Drug product	2022-03-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205525-001	8222292	2028-08-06	Drug substance, Drug product	2017-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205525-001	9345771	2028-08-06	Drug substance, Drug product	2017-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205525-001	10265293	2028-08-06	Drug substance, Drug product	2019-05-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205525-001	11253472	2028-08-06	Drug substance, Drug product	2022-03-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205525-001	8222292	2028-08-06	Drug substance, Drug product	2017-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205525-001	9345771	2028-08-06	Drug substance, Drug product	2017-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205525-001	10265293	2028-08-06	Drug substance, Drug product	2019-05-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205525-001	11253472	2028-08-06	Drug substance, Drug product	2022-03-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205525-001	8222292	2028-08-06	Drug substance, Drug product	2017-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205525-001	9345771	2028-08-06	Drug substance, Drug product	2017-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205525-001	10265293	2028-08-06	Drug substance, Drug product	2019-05-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205525-001	11253472	2028-08-06	Drug substance, Drug product	2022-03-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205525-001	8222292	2028-08-06	Drug substance, Drug product	2017-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205525-001	9345771	2028-08-06	Drug substance, Drug product	2017-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205525-001	10265293	2028-08-06	Drug substance, Drug product	2019-05-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205525-001	11253472	2028-08-06	Drug substance, Drug product	2022-03-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205525-001	8222292	2028-08-06	Drug substance, Drug product	2017-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205525-001	9345771	2028-08-06	Drug substance, Drug product	2017-03-30	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: SYNDROS

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DRONABINOL	5 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1928948	Internal RxNorm lookup
1928954	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
a7801c70-995d-46a2-91ee-141ef427c6b5	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
78613-201-30	SYNDROS	1 in 1 CARTON	SOLUTION	1		9
78613-201-30	SYNDROS	30 mL in 1 BOTTLE, GLASS	SOLUTION	30		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
78613-201-30	ML - Milliliter	78613-201	51880287-033d-4e12-9b3b-e0844e73013a	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78613-201	SYNDROS (DRONABINOL) SOLUTION [BENUVIA OPERATIONS, LLC]	7	Current NDC, Legacy NDC, 2 package rows	20240601_a7801c70-995d-46a2-91ee-141ef427c6b5.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
SYNDROS	DRONABINOL	Benuvia Operations, LLC	a7801c70-995d-46a2-91ee-141ef427c6b5	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205525 application number: NDA205525 ndc (product): 78613-201
SYNDROS	DRONABINOL	Wellhouse Pharma, LLC	3cdcb4f5-5af9-4ff7-b535-2a5cf4c6da89	2026-04-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205525 application number: NDA205525
DRONABINOL	DRONABINOL	Wellhouse Pharma, LLC	495aabae-3597-49dc-a5af-e328bcd937b7	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205525 application number: NDA205525
Dronabinol	DRONABINOL	Chartwell RX, LLC	44205ae6-b86a-485c-baf6-233a2c878640	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205525 application number: NDA205525

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
1928948	droNABinol 5 MG/mL Oral Solution	PSN	a7801c70-995d-46a2-91ee-141ef427c6b5	9
1928954	SYNDROS 5 MG/mL Oral Solution	PSN	a7801c70-995d-46a2-91ee-141ef427c6b5	9
1928954	dronabinol 5 MG/ML Oral Solution [Syndros]	SBD	a7801c70-995d-46a2-91ee-141ef427c6b5	9
1928948	dronabinol 5 MG/ML Oral Solution	SCD	a7801c70-995d-46a2-91ee-141ef427c6b5	9
1928948	dronabinol 5 MG/ML Oral Solution	SY	a7801c70-995d-46a2-91ee-141ef427c6b5	9
1928954	Syndros 5 MG/ML Oral Solution	SY	a7801c70-995d-46a2-91ee-141ef427c6b5	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
78613-201-30	78613020130	1 BOTTLE, GLASS in 1 CARTON (78613-201-30) / 30 mL in 1 BOTTLE, GLASS	2017-07-01	2027-04-30	No	No	Current