DRONABINOL

Product NDC: 42858-868
11-digit product format: 428580868
Labeler code: 42858
Product ID: 42858-868_5467a1be-b888-4f7c-9a62-5faf6c977b05
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DRONABINOL
Dosage form: CAPSULE
Route: ORAL
Labeler: Rhodes Pharmaceuticals L.P.
Application: ANDA078292
Marketing category: ANDA
Marketing start: 2018-06-26
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: 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	42858-868		D	Discontinued by firm		2026-08-07
excluded package	package	42858-868	42858-868-06	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	Approval date
A078292-001	DRONABINOL	DRONABINOL	2.5MG	CAPSULE / ORAL	2008-06-27
A078292-002	DRONABINOL	DRONABINOL	5MG	CAPSULE / ORAL	2008-06-27
A078292-003	DRONABINOL	DRONABINOL	10MG	CAPSULE / ORAL	2008-06-27

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL		2008-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL		2008-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL		2008-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL		2008-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL		2008-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL		2008-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL		2008-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL		2008-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL		2008-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL		2008-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL		2008-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL		2008-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL		2008-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL		2008-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL		2008-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL		2008-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL		2008-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL		2008-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL		2008-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL		2008-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL		2008-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL		2008-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL		2008-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL		2008-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL		2008-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL		2008-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL		2008-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL		2008-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL		2008-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL		2008-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL	AB	2008-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL	AB	2008-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL	AB	2008-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL	AB	2008-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL	AB	2008-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL	AB	2008-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL	AB	2008-06-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078292-002	DRONABINOL	5MG	CAPSULE / ORAL	AB	2008-06-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078292-003	DRONABINOL	10MG	CAPSULE / ORAL	AB	2008-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078292-001	DRONABINOL	2.5MG	CAPSULE / ORAL	AB	2008-06-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078292-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078292-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078292-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078292-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078292-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078292-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078292-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078292-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078292-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078292-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078292-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078292-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078292-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078292-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078292-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078292-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078292-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078292-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078292-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078292-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078292-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078292-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078292-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078292-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078292-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078292-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078292-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078292-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078292-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078292-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078292-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078292-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078292-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078292-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078292-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078292-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078292-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078292-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078292-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078292-001	AB	1	`c0c555d07b60…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
a078d9db-810e-ade7-7f79-e8c1623628f9	Product name	4	20200617
03fbef77-e64f-4d6b-9d24-bfd1671e5179	Product name	1	20190402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42858-868-06	EA - Each	42858-868	99d706d9-9ce5-4c6a-909f-e61f37c3f457	1	2018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42858-868	DRONABINOL CAPSULE [RHODES PHARMACEUTICALS L.P.]	5	Legacy NDC	20230318_3c06ccda-4819-40f8-b2db-fa294bb8a2fa.zip

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
42858-868-06	42858086806	60 CAPSULE in 1 BOTTLE (42858-868-06)	60 capsule	2018-06-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRONABINOL	American Health Packaging	2025-01-07	HUMAN PRESCRIPTION DRUG LABEL	8
DRONABINOL	Rhodes Pharmaceuticals L.P. \| Pharmaceutics International, Inc	2023-03-16	HUMAN PRESCRIPTION DRUG LABEL	5
DRONABINOL	Major Pharmaceuticals	2022-07-07	HUMAN PRESCRIPTION DRUG LABEL	4