Lyrica

Product NDC: 58151-238
11-digit product format: 581510238
Labeler code: 58151
Product ID: 58151-238_1c2af07d-faf4-4fc7-b724-c5166746956d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREGABALIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Viatris Specialty LLC
Application: NDA021446
Marketing category: NDA
Marketing start: 2025-06-17
Substance: PREGABALIN
Active strength: 75 mg/1
DEA schedule: CV
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 43.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021446-001	LYRICA	PREGABALIN	25MG	CAPSULE / ORAL	AB	RLD	2004-12-30
N021446-002	LYRICA	PREGABALIN	50MG	CAPSULE / ORAL	AB	RLD	2004-12-30
N021446-003	LYRICA	PREGABALIN	75MG	CAPSULE / ORAL	AB	RLD	2004-12-30
N021446-004	LYRICA	PREGABALIN	100MG	CAPSULE / ORAL	AB	RLD	2004-12-30
N021446-005	LYRICA	PREGABALIN	150MG	CAPSULE / ORAL	AB	RLD	2004-12-30
N021446-006	LYRICA	PREGABALIN	200MG	CAPSULE / ORAL	AB	RLD	2004-12-30
N021446-007	LYRICA	PREGABALIN	225MG	CAPSULE / ORAL	AB	RLD	2004-12-30
N021446-008	LYRICA	PREGABALIN	300MG	CAPSULE / ORAL	AB	RLD, RS	2004-12-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
N021446-001	AB
N021446-002	AB
N021446-003	AB
N021446-004	AB
N021446-005	AB
N021446-006	AB
N021446-007	AB
N021446-008	AB

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 9 · 344 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	N021446-001	LYRICA	25MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021446-002	LYRICA	50MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021446-003	LYRICA	75MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021446-004	LYRICA	100MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021446-005	LYRICA	150MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021446-006	LYRICA	200MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021446-007	LYRICA	225MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021446-008	LYRICA	300MG	CAPSULE / ORAL	AB	RLD, RS	2004-12-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021446-001	LYRICA	25MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021446-002	LYRICA	50MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021446-003	LYRICA	75MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021446-004	LYRICA	100MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021446-005	LYRICA	150MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021446-006	LYRICA	200MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021446-007	LYRICA	225MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021446-008	LYRICA	300MG	CAPSULE / ORAL	AB	RLD, RS	2004-12-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021446-001	LYRICA	25MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021446-002	LYRICA	50MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021446-003	LYRICA	75MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021446-004	LYRICA	100MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021446-005	LYRICA	150MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021446-006	LYRICA	200MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021446-007	LYRICA	225MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021446-008	LYRICA	300MG	CAPSULE / ORAL	AB	RLD, RS	2004-12-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021446-001	LYRICA	25MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021446-002	LYRICA	50MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021446-003	LYRICA	75MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021446-004	LYRICA	100MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021446-005	LYRICA	150MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021446-006	LYRICA	200MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021446-007	LYRICA	225MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021446-008	LYRICA	300MG	CAPSULE / ORAL	AB	RLD, RS	2004-12-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021446-001	LYRICA	25MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021446-002	LYRICA	50MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021446-003	LYRICA	75MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021446-004	LYRICA	100MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021446-005	LYRICA	150MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021446-006	LYRICA	200MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021446-007	LYRICA	225MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021446-008	LYRICA	300MG	CAPSULE / ORAL	AB	RLD, RS	2004-12-30	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 336 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	N021446-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021446-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021446-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021446-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021446-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021446-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021446-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021446-008	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021446-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021446-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021446-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021446-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021446-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021446-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021446-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021446-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021446-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021446-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021446-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021446-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021446-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021446-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021446-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021446-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021446-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021446-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021446-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021446-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021446-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021446-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021446-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021446-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021446-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021446-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021446-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021446-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021446-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021446-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021446-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021446-008	AB	1	`6a471c1ec25d…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021446-001	6001876*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-001	6197819*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-001	RE41920*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-002	6001876*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-002	6197819*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-002	RE41920*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-003	6001876*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-003	6197819*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-003	RE41920*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-004	6001876*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-004	6197819*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-004	RE41920*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-005	6001876*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-005	6197819*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-005	RE41920*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-006	6001876*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-006	6197819*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-006	RE41920*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-007	6001876*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-007	6197819*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-007	RE41920*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-008	6001876*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-008	6197819*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021446-008	RE41920*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021446-001	6001876*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021446-001	6197819*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021446-001	RE41920*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021446-002	6001876*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021446-002	6197819*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021446-002	RE41920*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021446-003	6001876*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021446-003	6197819*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021446-003	RE41920*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021446-004	6001876*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021446-004	6197819*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021446-004	RE41920*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021446-005	6001876*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021446-005	6197819*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021446-005	RE41920*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021446-006	6001876*PED	2019-06-30	Pediatric extension	`3f01610625f2…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 13 · 512 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021446-001	NPP	2022-05-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021446-001	PED	2022-11-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021446-002	NPP	2022-05-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021446-002	PED	2022-11-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021446-003	NPP	2022-05-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021446-003	PED	2022-11-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021446-004	NPP	2022-05-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021446-004	PED	2022-11-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021446-005	NPP	2022-05-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021446-005	PED	2022-11-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021446-006	NPP	2022-05-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021446-006	PED	2022-11-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021446-007	NPP	2022-05-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021446-007	PED	2022-11-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021446-008	NPP	2022-05-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021446-008	PED	2022-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021446-001	NPP	2022-05-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021446-001	PED	2022-11-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021446-002	NPP	2022-05-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021446-002	PED	2022-11-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021446-003	NPP	2022-05-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021446-003	PED	2022-11-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021446-004	NPP	2022-05-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021446-004	PED	2022-11-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021446-005	NPP	2022-05-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021446-005	PED	2022-11-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021446-006	NPP	2022-05-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021446-006	PED	2022-11-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021446-007	NPP	2022-05-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021446-007	PED	2022-11-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021446-008	NPP	2022-05-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021446-008	PED	2022-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021446-001	NPP	2022-05-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021446-001	PED	2022-11-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021446-002	NPP	2022-05-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021446-002	PED	2022-11-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021446-003	NPP	2022-05-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021446-003	PED	2022-11-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021446-004	NPP	2022-05-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021446-004	PED	2022-11-23	`4b0b4de00fa7…`

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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREGABALIN	75 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 · 18 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
483438	Internal RxNorm lookup
483440	Internal RxNorm lookup
483442	Internal RxNorm lookup
483444	Internal RxNorm lookup
483446	Internal RxNorm lookup
483448	Internal RxNorm lookup
483450	Internal RxNorm lookup
577127	Internal RxNorm lookup
607018	Internal RxNorm lookup
607020	Internal RxNorm lookup
607022	Internal RxNorm lookup
607024	Internal RxNorm lookup
607026	Internal RxNorm lookup
607028	Internal RxNorm lookup
607033	Internal RxNorm lookup
607038	Internal RxNorm lookup
898715	Internal RxNorm lookup
898718	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
d4734e7d-5079-455e-8ff5-8f4539c998a9	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
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
004d1029-ec13-fc89-74f4-3907cf5b6602	Product name	2	20140523
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58151-238-32	Lyrica	1 in 1 BLISTER PACK	CAPSULE	1	18
58151-238-77	Lyrica	90 in 1 BOTTLE	CAPSULE	90	18
58151-238-88	Lyrica	100 in 1 CARTON	CAPSULE	100	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58151-238-32	EA - Each	58151-238	f9f0e761-1631-49e0-83f9-ad0e295b8ff3	1	2025-10-14
58151-238-77	EA - Each	58151-238	93023ac9-b69d-4965-aba3-800bca9591bf	1	2025-07-08
58151-238-88	EA - Each	58151-238	be4cfc85-8730-417d-83b7-ec1c7e35ee48	1	2025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58151-238	LYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [VIATRIS SPECIALTY LLC]	11	Current NDC, 3 package rows	20250510_d4734e7d-5079-455e-8ff5-8f4539c998a9.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lyrica	PREGABALIN	Viatris Specialty LLC	d4734e7d-5079-455e-8ff5-8f4539c998a9	2025-04-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021446 application number: NDA021446 ndc (product): 58151-238
Lyrica	PREGABALIN	Parke-Davis Div of Pfizer Inc	60185c88-ecfd-46f9-adb9-b97c6b00a553	2020-06-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021446 application number: NDA021446

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
607018	Lyrica 100 MG Oral Capsule	PSN	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607020	Lyrica 150 MG Oral Capsule	PSN	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
898718	Lyrica 20 MG in 1 mL Oral Solution	PSN	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607022	Lyrica 200 MG Oral Capsule	PSN	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607024	Lyrica 225 MG Oral Capsule	PSN	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607026	Lyrica 25 MG Oral Capsule	PSN	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607028	Lyrica 300 MG Oral Capsule	PSN	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607033	Lyrica 50 MG Oral Capsule	PSN	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607038	Lyrica 75 MG Oral Capsule	PSN	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
483438	pregabalin 100 MG Oral Capsule	PSN	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
483440	pregabalin 150 MG Oral Capsule	PSN	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
898715	pregabalin 20 MG in 1 mL Oral Solution	PSN	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
483446	pregabalin 200 MG Oral Capsule	PSN	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
577127	pregabalin 225 MG Oral Capsule	PSN	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
483442	pregabalin 25 MG Oral Capsule	PSN	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
483444	pregabalin 300 MG Oral Capsule	PSN	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
483448	pregabalin 50 MG Oral Capsule	PSN	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
483450	pregabalin 75 MG Oral Capsule	PSN	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607018	pregabalin 100 MG Oral Capsule [Lyrica]	SBD	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607020	pregabalin 150 MG Oral Capsule [Lyrica]	SBD	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
898718	pregabalin 20 MG/ML Oral Solution [Lyrica]	SBD	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607022	pregabalin 200 MG Oral Capsule [Lyrica]	SBD	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607024	pregabalin 225 MG Oral Capsule [Lyrica]	SBD	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607026	pregabalin 25 MG Oral Capsule [Lyrica]	SBD	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607028	pregabalin 300 MG Oral Capsule [Lyrica]	SBD	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607033	pregabalin 50 MG Oral Capsule [Lyrica]	SBD	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607038	pregabalin 75 MG Oral Capsule [Lyrica]	SBD	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
483438	pregabalin 100 MG Oral Capsule	SCD	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
483440	pregabalin 150 MG Oral Capsule	SCD	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
898715	pregabalin 20 MG/ML Oral Solution	SCD	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
483446	pregabalin 200 MG Oral Capsule	SCD	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
577127	pregabalin 225 MG Oral Capsule	SCD	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
483442	pregabalin 25 MG Oral Capsule	SCD	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
483444	pregabalin 300 MG Oral Capsule	SCD	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
483448	pregabalin 50 MG Oral Capsule	SCD	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
483450	pregabalin 75 MG Oral Capsule	SCD	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607018	Lyrica 100 MG Oral Capsule	SY	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607020	Lyrica 150 MG Oral Capsule	SY	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
898718	Lyrica 20 MG per 1 ML Oral Solution	SY	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
898718	Lyrica 20 MG/ML Oral Solution	SY	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607022	Lyrica 200 MG Oral Capsule	SY	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607024	Lyrica 225 MG Oral Capsule	SY	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607026	Lyrica 25 MG Oral Capsule	SY	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607028	Lyrica 300 MG Oral Capsule	SY	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607033	Lyrica 50 MG Oral Capsule	SY	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
607038	Lyrica 75 MG Oral Capsule	SY	d4734e7d-5079-455e-8ff5-8f4539c998a9	18
898715	pregabalin 20 MG per 1 ML Oral Solution	SY	d4734e7d-5079-455e-8ff5-8f4539c998a9	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58151-238-32	58151023832	1 in 1 BLISTER PACK					Historical
58151-238-77	58151023877	90 CAPSULE in 1 BOTTLE (58151-238-77)	90 capsule	2025-06-17	No	No	Current
58151-238-88	58151023888	100 BLISTER PACK in 1 CARTON (58151-238-88) / 1 CAPSULE in 1 BLISTER PACK (58151-238-32)	100 blister pack	2025-09-24	No	No	Current