SYNDROS

Product NDC: 20482-335
11-digit product format: 204820335
Labeler code: 20482
Product ID: 20482-335_7bcc893e-abb1-48e3-a804-d41554d2a92f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dronabinol
Dosage form: SOLUTION
Route: ORAL
Labeler: Insys Therapeutics, Inc.
Application: NDA205525
Marketing category: NDA
Marketing start: 2017-07-27
Marketing end: 0000-00-00
Substance: DRONABINOL
Active strength: 5 mg/mL
Pharmacologic classes: Cannabinoid [EPC],Cannabinoids [CS]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2020-12-31
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	20482-335		I	Inactivated by FDA		2026-08-07
excluded package	package	20482-335	20482-335-30	I	Inactivated by FDA		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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	20482-335-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	20482-335-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	20482-335-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	20482-335-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	20482-335-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	20482-335-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	20482-335-30	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	20482-335-30	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	20482-335-30	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	20482-335-30	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	20482-335-30	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	20482-335-30	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	20482-335-30	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	20482-335-30	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	20482-335-30	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	20482-335-30	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	20482-335-30	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	20482-335-30	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	20482-335-30	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	20482-335-30	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		Y	Unknown FDA exclusion code: Y	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	20482-335-30	Y	Unknown FDA exclusion code: Y	`110d247fa046…`	`a55b01930146…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
20482-335-30	2020-09-27	C162847	48780-1	ab0e2407-314b-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use SYNDROS safely and effectively. See full prescribing information for SYNDROS. SYNDROS ® (dronabinol) oral solution, CII Initial U.S. Approval: 1985
20482-335-30	2020-09-25	C162847	48780-1	ab0e2407-314b-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use SYNDROS safely and effectively. See full prescribing information for SYNDROS. SYNDROS ® (dronabinol) oral solution, CII Initial U.S. Approval: 1985
20482-335-30	2020-07-22	C162847	48780-1	ab0e2407-314b-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use SYNDROS safely and effectively. See full prescribing information for SYNDROS. SYNDROS ® (dronabinol) oral solution, CII Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
20482-335-30	SYNDROS	1 in 1 CARTON	SOLUTION	1		12
20482-335-30	SYNDROS	30 mL in 1 BOTTLE, GLASS	SOLUTION	30		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
20482-335-30	ML - Milliliter	20482-335	883fd777-f38d-4a8e-afd7-9d8441a5d6f8	1	2017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
20482-335	SYNDROS (DRONABINOL) SOLUTION [INSYS THERAPEUTICS, INC.]	12	Legacy NDC, 2 package rows	20191214_c2bc83c1-f9fe-11e2-b778-0800200c9a66.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
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	c2bc83c1-f9fe-11e2-b778-0800200c9a66	12
1928954	SYNDROS 5 MG/mL Oral Solution	PSN	c2bc83c1-f9fe-11e2-b778-0800200c9a66	12
1928954	dronabinol 5 MG/ML Oral Solution [Syndros]	SBD	c2bc83c1-f9fe-11e2-b778-0800200c9a66	12
1928948	dronabinol 5 MG/ML Oral Solution	SCD	c2bc83c1-f9fe-11e2-b778-0800200c9a66	12
1928948	dronabinol 5 MG/ML Oral Solution	SY	c2bc83c1-f9fe-11e2-b778-0800200c9a66	12
1928954	Syndros 5 MG/ML Oral Solution	SY	c2bc83c1-f9fe-11e2-b778-0800200c9a66	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
20482-335-30	20482033530	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SYNDROS	Insys Therapeutics, Inc. \| Benuvia Therapeutics, Inc.	2019-12-11	HUMAN PRESCRIPTION DRUG LABEL	12