SEZABY

Product NDC: 62756-301
11-digit product format: 627560301
Labeler code: 62756
Product ID: 62756-301_842763a1-63ca-4721-b127-f997ac4aa659
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: phenobarbital sodium
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Sun Pharmaceutical Industries, Inc.
Application: NDA215910
Marketing category: NDA
Marketing start: 2022-12-25
Substance: PHENOBARBITAL SODIUM
Active strength: 100 mg/1
DEA schedule: CIV
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
N215910-001	SEZABY	PHENOBARBITAL SODIUM	100MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2022-11-17

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10
N215910-001	12636254	2042-04-07	U-3779	Drug product	2026-06-08

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215910-001	ODE-414	2029-11-17

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.

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	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215910-001	SEZABY	100MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2022-11-17	`a50c72e98297…`

Observed Orange Book patent history#

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	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215910-001	11857683	2042-04-07	U-3779	Drug product	2024-01-10	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215910-001	12636254	2042-04-07	U-3779	Drug product	2026-06-08	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215910-001	ODE-414	2029-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215910-001	ODE-414	2029-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215910-001	ODE-414	2029-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215910-001	ODE-414	2029-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215910-001	ODE-414	2029-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215910-001	ODE-414	2029-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215910-001	ODE-414	2029-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215910-001	ODE-414	2029-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215910-001	ODE-414	2029-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215910-001	ODE-414	2029-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215910-001	ODE-414	2029-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215910-001	ODE-414	2029-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215910-001	ODE-414	2029-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215910-001	ODE-414	2029-11-17	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215910-001	ODE-414	2029-11-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215910-001	ODE-414	2029-11-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215910-001	ODE-414	2029-11-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215910-001	ODE-414	2029-11-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215910-001	ODE-414	2029-11-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215910-001	ODE-414	2029-11-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215910-001	ODE-414	2029-11-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215910-001	ODE-414	2029-11-17	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215910-001	ODE-414	2029-11-17	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: SEZABY
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENOBARBITAL SODIUM	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SW9M9BB5K3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2624719	Internal RxNorm lookup
2624724	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
8c7d0402-4977-4c25-bc4b-11db91339e9a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e3e67a66-d325-4d80-8f9d-059e736d7b00	Product name	1	20230912

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62756-301-01	SEZABY	1 in 1 VIAL, SINGLE-DOSE	INJECTION	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62756-301-01	EA - Each	62756-301	c2027044-61ff-4f5e-9df0-553d98d14b40	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62756-301	SEZABY (PHENOBARBITAL SODIUM) INJECTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]	6	Current NDC, Legacy NDC, 1 package rows	20240927_8c7d0402-4977-4c25-bc4b-11db91339e9a.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
SEZABY	PHENOBARBITAL SODIUM	Sun Pharmaceutical Industries, Inc.	8c7d0402-4977-4c25-bc4b-11db91339e9a	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215910 application number: NDA215910 ndc (product): 62756-301

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SW9M9BB5K3	PHENOBARBITAL SODIUM	57-30-7	PHENOBARBITAL SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2624719	PHENobarbital sodium 100 MG Injection	PSN	8c7d0402-4977-4c25-bc4b-11db91339e9a	7
2624724	Sezaby 100 MG Injection	PSN	8c7d0402-4977-4c25-bc4b-11db91339e9a	7
2624724	phenobarbital sodium 100 MG Injection [Sezaby]	SBD	8c7d0402-4977-4c25-bc4b-11db91339e9a	7
2624719	phenobarbital sodium 100 MG Injection	SCD	8c7d0402-4977-4c25-bc4b-11db91339e9a	7
2624724	Sezaby 100 MG Injection	SY	8c7d0402-4977-4c25-bc4b-11db91339e9a	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62756-301-01	62756030101	1 INJECTION in 1 VIAL, SINGLE-DOSE (62756-301-01)	1 injection	2022-12-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SEZABY	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Medicare Limited	2025-12-23	HUMAN PRESCRIPTION DRUG LABEL	7