Lyrica CR

Product NDC: 58151-245
Requested package NDC: 58151-245-93
11-digit product format: 581510245
Labeler code: 58151
Product ID: 58151-245_67715d17-5ade-44ba-a5db-ba20d30d6da1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREGABALIN
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Viatris Specialty LLC
Application: NDA209501
Marketing category: NDA
Marketing start: 2024-11-26
Substance: PREGABALIN
Active strength: 82.5 mg/1
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	TE codes	RLD / RS	Approval date
N209501-001	LYRICA CR	PREGABALIN	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11
N209501-002	LYRICA CR	PREGABALIN	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11
N209501-003	LYRICA CR	PREGABALIN	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N209501-001	AB
N209501-002	AB
N209501-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209501-001	10022447	2026-11-02	U-2136		2018-08-16
N209501-001	10022447	2026-11-02	U-2137		2018-08-16
N209501-001	8945620	2026-11-02	U-2136	Drug product	2017-11-09
N209501-001	8945620	2026-11-02	U-2137	Drug product	2017-11-09
N209501-001	9144559	2026-11-02		Drug product	2017-11-09
N209501-001	10022447*PED	2027-05-02		Pediatric extension
N209501-001	8945620*PED	2027-05-02		Pediatric extension
N209501-001	9144559*PED	2027-05-02		Pediatric extension
N209501-002	10022447	2026-11-02	U-2136		2018-08-16
N209501-002	10022447	2026-11-02	U-2137		2018-08-16
N209501-002	8945620	2026-11-02	U-2136	Drug product	2017-11-09
N209501-002	8945620	2026-11-02	U-2137	Drug product	2017-11-09
N209501-002	9144559	2026-11-02		Drug product	2017-11-09
N209501-002	10022447*PED	2027-05-02		Pediatric extension
N209501-002	8945620*PED	2027-05-02		Pediatric extension
N209501-002	9144559*PED	2027-05-02		Pediatric extension
N209501-003	10022447	2026-11-02	U-2136		2018-08-16
N209501-003	10022447	2026-11-02	U-2137		2018-08-16
N209501-003	8945620	2026-11-02	U-2136	Drug product	2017-11-09
N209501-003	8945620	2026-11-02	U-2137	Drug product	2017-11-09
N209501-003	9144559	2026-11-02		Drug product	2017-11-09
N209501-003	10022447*PED	2027-05-02		Pediatric extension
N209501-003	8945620*PED	2027-05-02		Pediatric extension
N209501-003	9144559*PED	2027-05-02		Pediatric extension

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209501-002	LYRICA CR	165MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209501-003	LYRICA CR	330MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2017-10-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209501-001	LYRICA CR	82.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2017-10-11	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N209501-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209501-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209501-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209501-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209501-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209501-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209501-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209501-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209501-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209501-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209501-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209501-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209501-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209501-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209501-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209501-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209501-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209501-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209501-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209501-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209501-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209501-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209501-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209501-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209501-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209501-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209501-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209501-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209501-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209501-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209501-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209501-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209501-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209501-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209501-001	AB	1	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 27 · 1,056 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209501-001	10022447	2026-11-02	U-2137		2018-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-001	10022447	2026-11-02	U-2136		2018-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-001	8945620	2026-11-02	U-2136	Drug product	2017-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-001	8945620	2026-11-02	U-2137	Drug product	2017-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-001	9144559	2026-11-02		Drug product	2017-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-001	10022447*PED	2027-05-02		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-001	8945620*PED	2027-05-02		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-001	9144559*PED	2027-05-02		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-002	10022447	2026-11-02	U-2137		2018-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-002	10022447	2026-11-02	U-2136		2018-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-002	8945620	2026-11-02	U-2137	Drug product	2017-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-002	8945620	2026-11-02	U-2136	Drug product	2017-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-002	9144559	2026-11-02		Drug product	2017-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-002	10022447*PED	2027-05-02		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-002	8945620*PED	2027-05-02		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-002	9144559*PED	2027-05-02		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-003	10022447	2026-11-02	U-2137		2018-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-003	10022447	2026-11-02	U-2136		2018-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-003	8945620	2026-11-02	U-2137	Drug product	2017-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-003	8945620	2026-11-02	U-2136	Drug product	2017-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-003	9144559	2026-11-02		Drug product	2017-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-003	10022447*PED	2027-05-02		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-003	8945620*PED	2027-05-02		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209501-003	9144559*PED	2027-05-02		Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209501-001	10022447	2026-11-02	U-2137		2018-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209501-001	10022447	2026-11-02	U-2136		2018-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209501-001	8945620	2026-11-02	U-2136	Drug product	2017-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209501-001	8945620	2026-11-02	U-2137	Drug product	2017-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209501-001	9144559	2026-11-02		Drug product	2017-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209501-001	10022447*PED	2027-05-02		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209501-001	8945620*PED	2027-05-02		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209501-001	9144559*PED	2027-05-02		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209501-002	10022447	2026-11-02	U-2137		2018-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209501-002	10022447	2026-11-02	U-2136		2018-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209501-002	8945620	2026-11-02	U-2137	Drug product	2017-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209501-002	8945620	2026-11-02	U-2136	Drug product	2017-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209501-002	9144559	2026-11-02		Drug product	2017-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209501-002	10022447*PED	2027-05-02		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209501-002	8945620*PED	2027-05-02		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209501-002	9144559*PED	2027-05-02		Pediatric extension		`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N209501-001	NP	2020-10-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209501-001	PED	2021-04-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209501-002	NP	2020-10-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209501-002	PED	2021-04-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209501-003	NP	2020-10-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209501-003	PED	2021-04-11	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N209501-001	PED	2021-04-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209501-002	PED	2021-04-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209501-003	PED	2021-04-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209501-001	PED	2021-04-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209501-002	PED	2021-04-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209501-003	PED	2021-04-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209501-001	PED	2021-04-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209501-002	PED	2021-04-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209501-003	PED	2021-04-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209501-001	NP	2020-10-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209501-001	PED	2021-04-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209501-002	NP	2020-10-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209501-002	PED	2021-04-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209501-003	NP	2020-10-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209501-003	PED	2021-04-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209501-001	NP	2020-10-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209501-001	PED	2021-04-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209501-002	NP	2020-10-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209501-002	PED	2021-04-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209501-003	NP	2020-10-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209501-003	PED	2021-04-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209501-001	NP	2020-10-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209501-001	PED	2021-04-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209501-002	NP	2020-10-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209501-002	PED	2021-04-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209501-003	NP	2020-10-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209501-003	PED	2021-04-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209501-001	NP	2020-10-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209501-001	PED	2021-04-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209501-002	NP	2020-10-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209501-002	PED	2021-04-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209501-003	NP	2020-10-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209501-003	PED	2021-04-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209501-001	NP	2020-10-11	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREGABALIN	82.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
55JG375S6M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1988974	Internal RxNorm lookup
1988977	Internal RxNorm lookup
1988980	Internal RxNorm lookup
1994389	Internal RxNorm lookup
1994392	Internal RxNorm lookup
1994395	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
f280bbd8-2af2-444a-bd96-e409337ca6dd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
441d8579-bd15-4585-93f4-9de3db2d851d	Product name	4	20251114
004d1029-ec13-fc89-74f4-3907cf5b6602	Product name	2	20140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58151-245-93	Lyrica CR	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58151-245-93	EA - Each	58151-245	8db1db63-2c82-4f46-9404-67c8c13f58e9	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58151-245	LYRICA CR (PREGABALIN) TABLET, FILM COATED, EXTENDED RELEASE [VIATRIS SPECIALTY LLC]	5	Current NDC, 1 package rows	20250508_f280bbd8-2af2-444a-bd96-e409337ca6dd.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
Lyrica CR	PREGABALIN	Viatris Specialty LLC	f280bbd8-2af2-444a-bd96-e409337ca6dd	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209501 application number: NDA209501 ndc (package): 58151-245-93 ndc (product): 58151-245 ndc11 (package): 58151024593

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
55JG375S6M	PREGABALIN	148553-50-8	PREGABALIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1994389	Lyrica CR 165 MG 24HR Extended Release Oral Tablet	PSN	f280bbd8-2af2-444a-bd96-e409337ca6dd	7
1994392	Lyrica CR 330 MG 24HR Extended Release Oral Tablet	PSN	f280bbd8-2af2-444a-bd96-e409337ca6dd	7
1994395	Lyrica CR 82.5 MG 24HR Extended Release Oral Tablet	PSN	f280bbd8-2af2-444a-bd96-e409337ca6dd	7
1988974	pregabalin 165 MG 24HR Extended Release Oral Tablet	PSN	f280bbd8-2af2-444a-bd96-e409337ca6dd	7
1988977	pregabalin 330 MG 24HR Extended Release Oral Tablet	PSN	f280bbd8-2af2-444a-bd96-e409337ca6dd	7
1988980	pregabalin 82.5 MG 24HR Extended Release Oral Tablet	PSN	f280bbd8-2af2-444a-bd96-e409337ca6dd	7
1994389	24 HR pregabalin 165 MG Extended Release Oral Tablet [Lyrica]	SBD	f280bbd8-2af2-444a-bd96-e409337ca6dd	7
1994392	24 HR pregabalin 330 MG Extended Release Oral Tablet [Lyrica]	SBD	f280bbd8-2af2-444a-bd96-e409337ca6dd	7
1994395	24 HR pregabalin 82.5 MG Extended Release Oral Tablet [Lyrica]	SBD	f280bbd8-2af2-444a-bd96-e409337ca6dd	7
1988974	24 HR pregabalin 165 MG Extended Release Oral Tablet	SCD	f280bbd8-2af2-444a-bd96-e409337ca6dd	7
1988977	24 HR pregabalin 330 MG Extended Release Oral Tablet	SCD	f280bbd8-2af2-444a-bd96-e409337ca6dd	7
1988980	24 HR pregabalin 82.5 MG Extended Release Oral Tablet	SCD	f280bbd8-2af2-444a-bd96-e409337ca6dd	7
1994389	24 HR Lyrica 165 MG Extended Release Oral Tablet	SY	f280bbd8-2af2-444a-bd96-e409337ca6dd	7
1994392	24 HR Lyrica 330 MG Extended Release Oral Tablet	SY	f280bbd8-2af2-444a-bd96-e409337ca6dd	7
1994395	24 HR Lyrica 82.5 MG Extended Release Oral Tablet	SY	f280bbd8-2af2-444a-bd96-e409337ca6dd	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
58151-245-93	58151024593	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-245-93)	2024-11-26	No	No	Current