Elepsia XR

Product NDC: 47133-574
Requested package NDC: 47133-574-13
11-digit product format: 471330574
Labeler code: 47133
Product ID: 47133-574_be26dd04-d8a3-42c3-ab44-210dff9a0e3b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Levetiracetam
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Sun Pharma Advanced Research Company Limited
Application: NDA204417
Marketing category: NDA
Marketing start: 2019-05-17
Marketing end: 0000-00-00
Substance: LEVETIRACETAM
Active strength: 1000 mg/1
Pharmacologic classes: Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	47133-574	47133-574-13	D	Discontinued by firm		2026-08-17

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 · 10 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204417-001	ELEPSIA XR	LEVETIRACETAM	1GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2018-12-20
N204417-002	ELEPSIA XR	LEVETIRACETAM	1.5GM	TABLET, EXTENDED RELEASE / ORAL		RLD	2018-12-20

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N204417-001	8425938	2026-02-22	Drug product	2019-01-11
N204417-001	8535717	2026-02-22	Drug product	2019-01-11
N204417-001	8163306	2027-09-03	Drug product	2019-01-11
N204417-001	8431156	2027-10-31	Drug product	2019-01-11
N204417-001	8470367	2027-10-31	Drug product	2019-01-11
N204417-002	8425938	2026-02-22	Drug product	2019-01-11
N204417-002	8535717	2026-02-22	Drug product	2019-01-11
N204417-002	8163306	2027-09-03	Drug product	2019-01-11
N204417-002	8431156	2027-10-31	Drug product	2019-01-11
N204417-002	8470367	2027-10-31	Drug product	2019-01-11

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N204417-001	ELEPSIA XR	1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204417-002	ELEPSIA XR	1.5GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204417-001	ELEPSIA XR	1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204417-002	ELEPSIA XR	1.5GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204417-001	ELEPSIA XR	1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204417-002	ELEPSIA XR	1.5GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204417-001	ELEPSIA XR	1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204417-002	ELEPSIA XR	1.5GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204417-001	ELEPSIA XR	1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204417-002	ELEPSIA XR	1.5GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204417-001	ELEPSIA XR	1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204417-002	ELEPSIA XR	1.5GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204417-001	ELEPSIA XR	1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204417-002	ELEPSIA XR	1.5GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204417-001	ELEPSIA XR	1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204417-002	ELEPSIA XR	1.5GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204417-001	ELEPSIA XR	1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204417-002	ELEPSIA XR	1.5GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204417-001	ELEPSIA XR	1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204417-002	ELEPSIA XR	1.5GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204417-001	ELEPSIA XR	1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204417-002	ELEPSIA XR	1.5GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204417-001	ELEPSIA XR	1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204417-002	ELEPSIA XR	1.5GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204417-001	ELEPSIA XR	1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204417-002	ELEPSIA XR	1.5GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204417-001	ELEPSIA XR	1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204417-002	ELEPSIA XR	1.5GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204417-001	ELEPSIA XR	1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204417-002	ELEPSIA XR	1.5GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204417-001	ELEPSIA XR	1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204417-002	ELEPSIA XR	1.5GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2018-12-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204417-001	ELEPSIA XR	1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204417-002	ELEPSIA XR	1.5GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2018-12-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204417-001	ELEPSIA XR	1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204417-002	ELEPSIA XR	1.5GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2018-12-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204417-001	ELEPSIA XR	1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204417-002	ELEPSIA XR	1.5GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2018-12-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204417-001	ELEPSIA XR	1GM	TABLET, EXTENDED RELEASE / ORAL	RLD	2018-12-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204417-002	ELEPSIA XR	1.5GM	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2018-12-20	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 420 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N204417-001	8425938	2026-02-22	Drug product	2019-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204417-001	8535717	2026-02-22	Drug product	2019-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204417-001	8163306	2027-09-03	Drug product	2019-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204417-001	8431156	2027-10-31	Drug product	2019-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204417-001	8470367	2027-10-31	Drug product	2019-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204417-002	8425938	2026-02-22	Drug product	2019-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204417-002	8535717	2026-02-22	Drug product	2019-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204417-002	8163306	2027-09-03	Drug product	2019-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204417-002	8431156	2027-10-31	Drug product	2019-01-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204417-002	8470367	2027-10-31	Drug product	2019-01-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204417-001	8425938	2026-02-22	Drug product	2019-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204417-001	8535717	2026-02-22	Drug product	2019-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204417-001	8163306	2027-09-03	Drug product	2019-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204417-001	8431156	2027-10-31	Drug product	2019-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204417-001	8470367	2027-10-31	Drug product	2019-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204417-002	8425938	2026-02-22	Drug product	2019-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204417-002	8535717	2026-02-22	Drug product	2019-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204417-002	8163306	2027-09-03	Drug product	2019-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204417-002	8431156	2027-10-31	Drug product	2019-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204417-002	8470367	2027-10-31	Drug product	2019-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204417-001	8425938	2026-02-22	Drug product	2019-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204417-001	8535717	2026-02-22	Drug product	2019-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204417-001	8163306	2027-09-03	Drug product	2019-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204417-001	8431156	2027-10-31	Drug product	2019-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204417-001	8470367	2027-10-31	Drug product	2019-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204417-002	8425938	2026-02-22	Drug product	2019-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204417-002	8535717	2026-02-22	Drug product	2019-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204417-002	8163306	2027-09-03	Drug product	2019-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204417-002	8431156	2027-10-31	Drug product	2019-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204417-002	8470367	2027-10-31	Drug product	2019-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204417-001	8425938	2026-02-22	Drug product	2019-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204417-001	8535717	2026-02-22	Drug product	2019-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204417-001	8163306	2027-09-03	Drug product	2019-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204417-001	8431156	2027-10-31	Drug product	2019-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204417-001	8470367	2027-10-31	Drug product	2019-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204417-002	8425938	2026-02-22	Drug product	2019-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204417-002	8535717	2026-02-22	Drug product	2019-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204417-002	8163306	2027-09-03	Drug product	2019-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204417-002	8431156	2027-10-31	Drug product	2019-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204417-002	8470367	2027-10-31	Drug product	2019-01-11	`6a471c1ec25d…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
47133-574-13	2025-07-15	These highlights do not include all the information needed to use ELEPSIA XR safely and effectively. See full prescribing information for ELEPSIA XR. ELEPSIA™ XR (levetiracetam) extended-release tablets, for oral use Initial U.S. Approval: 1999
47133-574-83	2025-07-15	These highlights do not include all the information needed to use ELEPSIA XR safely and effectively. See full prescribing information for ELEPSIA XR. ELEPSIA™ XR (levetiracetam) extended-release tablets, for oral use Initial U.S. Approval: 1999
47133-574-88	2025-07-15	These highlights do not include all the information needed to use ELEPSIA XR safely and effectively. See full prescribing information for ELEPSIA XR. ELEPSIA™ XR (levetiracetam) extended-release tablets, for oral use Initial U.S. Approval: 1999
47133-574-13	2025-01-30	These highlights do not include all the information needed to use ELEPSIA XR safely and effectively. See full prescribing information for ELEPSIA XR. ELEPSIA™ XR (levetiracetam) extended-release tablets, for oral use Initial U.S. Approval: 1999
47133-574-83	2025-01-30	These highlights do not include all the information needed to use ELEPSIA XR safely and effectively. See full prescribing information for ELEPSIA XR. ELEPSIA™ XR (levetiracetam) extended-release tablets, for oral use Initial U.S. Approval: 1999
47133-574-88	2025-01-30	These highlights do not include all the information needed to use ELEPSIA XR safely and effectively. See full prescribing information for ELEPSIA XR. ELEPSIA™ XR (levetiracetam) extended-release tablets, for oral use Initial U.S. Approval: 1999

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEVETIRACETAM	ACTIVE INGREDIENT	44YRR34555	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
LEVETIRACETAM	ACTIVE MOIETY	44YRR34555	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
DIBUTYL SEBACATE	INACTIVE INGREDIENT	4W5IH7FLNY	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	INACTIVE INGREDIENT	905HNO1SIH	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47133-574	ELEPSIA XR (LEVETIRACETAM) TABLET, EXTENDED RELEASE [SUN PHARMA ADVANCED RESEARCH COMPANY LIMITED]	9	Legacy NDC	20210108_12e147dc-4f5b-4117-8a8e-a8c429ad0217.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
ELEPSIA XR 1000 MG	LEVETIRACETAM	TRIPOINT THERAPEUTICS, LLC	cac83d47-88a2-4447-a0c0-90b44ffda0ac	2024-03-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204417 application number: NDA204417

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
44YRR34555	LEVETIRACETAM	102767-28-2	LEVETIRACETAM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47133-574-13	47133057413	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (47133-574-13)	2019-05-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Elepsia XR	Sun Pharma Advanced Research Company Limited \| Sun Pharmaceutical Industries Limited	2021-01-06	HUMAN PRESCRIPTION DRUG LABEL	9