Epidiolex

Product NDC: 70127-100
11-digit product format: 701270100
Labeler code: 70127
Product ID: 70127-100_4552ca49-8f8c-418f-9029-03f6eda8a7b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cannabidiol
Dosage form: SOLUTION
Route: ORAL
Labeler: Jazz Pharmaceuticals, Inc.
Application: NDA210365
Marketing category: NDA
Marketing start: 2018-10-05
Substance: CANNABIDIOL
Active strength: 100 mg/mL
Pharmacologic classes: Cannabinoids [CS], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
N210365-001	EPIDIOLEX	CANNABIDIOL	100MG/ML	SOLUTION / ORAL		RLD, RS	2018-09-28

Orange Book patents#

Current patent rows page 1 of 1 · 57 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210365-001	10092525	2035-06-17	U-2427		2018-10-25
N210365-001	10111840	2035-06-17	U-2442		2018-11-27
N210365-001	10111840	2035-06-17	U-2443		2018-11-27
N210365-001	10137095	2035-06-17	U-2454		2018-12-17
N210365-001	10137095	2035-06-17	U-2455		2018-12-17
N210365-001	10603288	2035-06-17	U-2780		2020-04-27
N210365-001	10603288	2035-06-17	U-2781		2020-04-27
N210365-001	10603288	2035-06-17	U-2782		2020-04-27
N210365-001	10603288	2035-06-17	U-2783		2020-04-27
N210365-001	10709671	2035-06-17	U-2862		2020-07-30
N210365-001	10709673	2035-06-17		Drug product	2020-07-30
N210365-001	10709674	2035-06-17	U-2780		2020-07-30
N210365-001	10709674	2035-06-17	U-2781		2020-07-30
N210365-001	10849860	2035-06-17	U-2427		2020-11-18
N210365-001	10849860	2035-06-17	U-2454		2020-11-18
N210365-001	10966939	2035-06-17	U-2780	Drug product	2021-04-30
N210365-001	10966939	2035-06-17	U-2781	Drug product	2021-04-30
N210365-001	11154516	2035-06-17	U-3235		2021-11-04
N210365-001	11154516	2035-06-17	U-3236		2021-11-04
N210365-001	11311498	2035-06-17	U-3375		2022-05-20
N210365-001	11311498	2035-06-17	U-3376		2022-05-20
N210365-001	11357741	2035-06-17	U-2862		2022-07-13
N210365-001	11446258	2035-06-17	U-2780		2022-10-12
N210365-001	11446258	2035-06-17	U-2781		2022-10-12
N210365-001	11446258	2035-06-17	U-3071		2022-10-12
N210365-001	11633369	2035-06-17	U-2780	Drug product	2023-05-24
N210365-001	11633369	2035-06-17	U-2781	Drug product	2023-05-24
N210365-001	11633369	2035-06-17	U-3071	Drug product	2023-05-24
N210365-001	11701330	2035-06-17	U-2780		2023-08-15
N210365-001	11701330	2035-06-17	U-2781		2023-08-15
N210365-001	11766411	2035-06-17	U-2781		2023-10-19
N210365-001	11963937	2035-06-17	U-2780		2024-05-21
N210365-001	11963937	2035-06-17	U-2781		2024-05-21
N210365-001	12064399	2035-06-17	U-3988		2024-09-19
N210365-001	12064399	2035-06-17	U-3989		2024-09-19
N210365-001	9949937	2035-06-17	U-2421		2018-10-25
N210365-001	9956183	2035-06-17	U-2422		2018-10-25
N210365-001	9956183	2035-06-17	U-2423		2018-10-25
N210365-001	9956184	2035-06-17	U-2424		2018-10-25
N210365-001	9956185	2035-06-17	U-2425		2018-10-25
N210365-001	9956186	2035-06-17	U-2426		2018-10-25
N210365-001	10918608	2035-10-13	U-3071		2021-02-26
N210365-001	10918608	2035-10-13	U-3072		2021-02-26
N210365-001	10918608	2035-10-13	U-3073		2021-02-26
N210365-001	11065209	2035-10-13	U-3071		2021-08-17
N210365-001	11096905	2035-10-13	U-2780	Drug substance, Drug product	2021-09-16
N210365-001	11096905	2035-10-13	U-2781	Drug substance, Drug product	2021-09-16
N210365-001	11400055	2035-10-13	U-3071		2022-08-31
N210365-001	11207292	2039-04-26	U-3235	Drug substance	2022-01-19
N210365-001	11207292	2039-04-26	U-3236	Drug substance	2022-01-19
N210365-001	11207292	2039-04-26	U-3277	Drug substance	2022-01-19
N210365-001	11865102	2039-04-26	U-2781	Drug substance, Drug product	2024-01-30
N210365-001	11865102	2039-04-26	U-3236	Drug substance, Drug product	2024-01-30
N210365-001	11865102	2039-04-26	U-3277	Drug substance, Drug product	2024-01-30
N210365-001	11160795	2041-03-01	U-3233		2021-11-04
N210365-001	11406623	2041-03-01	U-3233		2022-08-31
N210365-001	12102619	2041-03-01	U-3233		2024-10-31

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N210365-001	M-270	2026-10-20
N210365-001	ODE-326	2027-07-31
N210365-001	ODE-332	2027-07-31

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	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210365-001	EPIDIOLEX	100MG/ML	SOLUTION / ORAL	RLD, RS	2018-09-28	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 44 · 1,748 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210365-001	10092525	2035-06-17	U-2427		2018-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	10111840	2035-06-17	U-2443		2018-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	10111840	2035-06-17	U-2442		2018-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	10137095	2035-06-17	U-2454		2018-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	10137095	2035-06-17	U-2455		2018-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	10603288	2035-06-17	U-2780		2020-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	10603288	2035-06-17	U-2781		2020-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	10603288	2035-06-17	U-2782		2020-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	10603288	2035-06-17	U-2783		2020-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	10709671	2035-06-17	U-2862		2020-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	10709673	2035-06-17		Drug product	2020-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	10709674	2035-06-17	U-2781		2020-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	10709674	2035-06-17	U-2780		2020-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	10849860	2035-06-17	U-2427		2020-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	10849860	2035-06-17	U-2454		2020-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	10966939	2035-06-17	U-2780	Drug product	2021-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	10966939	2035-06-17	U-2781	Drug product	2021-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	11154516	2035-06-17	U-3235		2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	11154516	2035-06-17	U-3236		2021-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	11311498	2035-06-17	U-3375		2022-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	11311498	2035-06-17	U-3376		2022-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	11357741	2035-06-17	U-2862		2022-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	11446258	2035-06-17	U-2780		2022-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	11446258	2035-06-17	U-2781		2022-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	11446258	2035-06-17	U-3071		2022-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	11633369	2035-06-17	U-2780	Drug product	2023-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	11633369	2035-06-17	U-3071	Drug product	2023-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	11633369	2035-06-17	U-2781	Drug product	2023-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	11701330	2035-06-17	U-2780		2023-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	11701330	2035-06-17	U-2781		2023-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	11766411	2035-06-17	U-2781		2023-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	11963937	2035-06-17	U-2780		2024-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	11963937	2035-06-17	U-2781		2024-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	12064399	2035-06-17	U-3988		2024-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	12064399	2035-06-17	U-3989		2024-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	9949937	2035-06-17	U-2421		2018-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	9956183	2035-06-17	U-2422		2018-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	9956183	2035-06-17	U-2423		2018-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	9956184	2035-06-17	U-2424		2018-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	9956185	2035-06-17	U-2425		2018-10-25	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 169 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210365-001	M-270	2026-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	ODE-326	2027-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210365-001	ODE-332	2027-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210365-001	ODE-216	2025-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210365-001	M-270	2026-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210365-001	ODE-326	2027-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210365-001	ODE-332	2027-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210365-001	ODE-216	2025-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210365-001	M-270	2026-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210365-001	ODE-326	2027-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210365-001	ODE-332	2027-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210365-001	ODE-216	2025-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210365-001	M-270	2026-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210365-001	ODE-326	2027-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210365-001	ODE-332	2027-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210365-001	ODE-216	2025-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210365-001	M-270	2026-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210365-001	ODE-326	2027-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210365-001	ODE-332	2027-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210365-001	ODE-216	2025-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210365-001	M-270	2026-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210365-001	ODE-326	2027-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210365-001	ODE-332	2027-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210365-001	ODE-216	2025-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210365-001	M-270	2026-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210365-001	ODE-326	2027-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210365-001	ODE-332	2027-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210365-001	ODE-216	2025-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210365-001	M-270	2026-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210365-001	ODE-326	2027-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210365-001	ODE-332	2027-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210365-001	ODE-216	2025-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210365-001	M-270	2026-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210365-001	ODE-326	2027-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210365-001	ODE-332	2027-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210365-001	ODE-216	2025-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210365-001	M-270	2026-10-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210365-001	ODE-326	2027-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210365-001	ODE-332	2027-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210365-001	ODE-216	2025-09-28	`79d66fd596c7…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CANNABIDIOL	100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
19GBJ60SN5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2058900	Internal RxNorm lookup
2058906	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
8bf27097-4870-43fb-94f0-f3d0871d1eec	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4d7a96d5-8256-4268-9a6c-25ea66d321fe	Product name	1	20180814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70127-100-01	Epidiolex	100 mL in 1 BOTTLE, GLASS	SOLUTION	100	34
70127-100-06	Epidiolex	60 mL in 1 BOTTLE, GLASS	SOLUTION	60	34
70127-100-10	Epidiolex	1 in 1 CARTON	SOLUTION	1	34
70127-100-60	Epidiolex	1 in 1 CARTON	SOLUTION	1	34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70127-100-01	ML - Milliliter	70127-100	0eef3365-ea11-4bd5-9635-c98e8b05a98d	1	2018-11-06
70127-100-06	ML - Milliliter	70127-100	c40d7df0-d6a4-4d13-9d26-370b0ca3315b	1	2021-10-08
70127-100-10	ML - Milliliter	70127-100	28a2b74c-3943-45f8-8fa3-dbd3a2448576	1	2018-11-06
70127-100-60	ML - Milliliter	70127-100	ae63fb08-df61-4e7d-be8b-1608019c88b4	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70127-100	EPIDIOLEX (CANNABIDIOL) SOLUTION [JAZZ PHARMACEUTICALS, INC.]	31	Current NDC, Legacy NDC, 4 package rows	20250409_8bf27097-4870-43fb-94f0-f3d0871d1eec.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Epidiolex	CANNABIDIOL	Jazz Pharmaceuticals, Inc.	8bf27097-4870-43fb-94f0-f3d0871d1eec	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210365 application number: NDA210365 ndc (product): 70127-100

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
19GBJ60SN5	CANNABIDIOL	13956-29-1	CANNABIDIOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2058900	cannabidiol 100 MG/mL Oral Solution	PSN	8bf27097-4870-43fb-94f0-f3d0871d1eec	34
2058906	Epidiolex 100 MG/mL Oral Solution	PSN	8bf27097-4870-43fb-94f0-f3d0871d1eec	34
2058906	cannabidiol 100 MG/ML Oral Solution [Epidiolex]	SBD	8bf27097-4870-43fb-94f0-f3d0871d1eec	34
2058900	cannabidiol 100 MG/ML Oral Solution	SCD	8bf27097-4870-43fb-94f0-f3d0871d1eec	34
2058906	Epidiolex 100 MG/ML Oral Solution	SY	8bf27097-4870-43fb-94f0-f3d0871d1eec	34

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70127-100-01	70127010001	100 mL in 1 BOTTLE, GLASS	100 ml					Historical
70127-100-06	70127010006	60 mL in 1 BOTTLE, GLASS	60 ml					Historical
70127-100-10	70127010010	1 BOTTLE, GLASS in 1 CARTON (70127-100-10) / 100 mL in 1 BOTTLE, GLASS (70127-100-01)		2018-10-05	0000-00-00	No	No	Current
70127-100-60	70127010060	1 BOTTLE, GLASS in 1 CARTON (70127-100-60) / 60 mL in 1 BOTTLE, GLASS (70127-100-06)		2021-10-06	0000-00-00	No	No	Current