Lyrica

Product NDC: 49999-895
11-digit product format: 499990895
Labeler code: 49999
Product ID: 49999-895_0fa8fb58-9300-4ad5-8848-3f15aa645fb3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREGABALIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: NDA021446
Marketing category: NDA
Marketing start: 2011-02-10
Marketing end: 2021-09-30
Substance: PREGABALIN
Active strength: 75 mg/1
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49999-895		D	Discontinued by firm	2026-08-11
excluded package	package	49999-895	49999-895-30	D	Discontinued by firm	2026-08-11
excluded package	package	49999-895	49999-895-60	D	Discontinued by firm	2026-08-11
excluded package	package	49999-895	49999-895-90	D	Discontinued by firm	2026-08-11

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49999-895-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49999-895-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49999-895-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49999-895-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49999-895-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49999-895-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49999-895-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49999-895-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49999-895-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49999-895-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49999-895-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49999-895-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49999-895-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49999-895-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49999-895-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49999-895-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49999-895-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49999-895-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49999-895-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49999-895-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49999-895-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49999-895-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49999-895-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49999-895-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49999-895-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49999-895-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49999-895-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49999-895-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49999-895-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49999-895-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49999-895-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49999-895-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49999-895-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49999-895-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49999-895-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49999-895-60	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 328 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
2026-02-19 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…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021446-001	LYRICA	25MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021446-002	LYRICA	50MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021446-003	LYRICA	75MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021446-004	LYRICA	100MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021446-005	LYRICA	150MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021446-006	LYRICA	200MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021446-007	LYRICA	225MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021446-008	LYRICA	300MG	CAPSULE / ORAL	AB	RLD, RS	2004-12-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021446-001	LYRICA	25MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021446-002	LYRICA	50MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021446-003	LYRICA	75MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021446-004	LYRICA	100MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021446-005	LYRICA	150MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021446-006	LYRICA	200MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021446-007	LYRICA	225MG	CAPSULE / ORAL	AB	RLD	2004-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021446-008	LYRICA	300MG	CAPSULE / ORAL	AB	RLD, RS	2004-12-30	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 320 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021446-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021446-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021446-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021446-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021446-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021446-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021446-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021446-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021446-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021446-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021446-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021446-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021446-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021446-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021446-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021446-008	AB	1	`b8a1b40f171c…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49999-895-30	EA - Each	49999-895	f9ae23a2-4a77-431b-a8e2-bf809baa1617	1	2012-07-24
49999-895-60	EA - Each	49999-895	c06e8b80-b12e-4a1c-804d-100c723974ce	1	2012-07-24
49999-895-90	EA - Each	49999-895	d08d7416-0c51-4ae3-a247-2dafaf19cc7a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PREGABALIN	ACTIVE INGREDIENT	55JG375S6M	LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3363
PREGABALIN	ACTIVE MOIETY	55JG375S6M	LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3363
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3363
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3363
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3363
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3363
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3363
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3363
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3363
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3363
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3363
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3363
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3363

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49999-895-30	49999089530	30 CAPSULE in 1 BOTTLE, PLASTIC (49999-895-30)	30 capsule	2011-02-10	2021-09-30	No	No	Current
49999-895-60	49999089560	60 CAPSULE in 1 BOTTLE, PLASTIC (49999-895-60)	60 capsule	2011-02-10	2021-09-30	No	No	Current
49999-895-90	49999089590	90 CAPSULE in 1 BOTTLE, PLASTIC (49999-895-90)	90 capsule	2011-02-10	2021-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lyrica	Lake Erie Medical DBA Quality Care Products LLC	2021-01-11	HUMAN PRESCRIPTION DRUG LABEL	3367