Lyrica

Product NDC: 50436-1265
11-digit product format: 504361265
Labeler code: 50436
Product ID: 50436-1265_d25545fa-12a6-48d8-bd62-67c162316019
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREGABALIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Unit Dose Services
Application: NDA021446
Marketing category: NDA
Marketing start: 2004-12-30
Marketing end: 0000-00-00
Substance: PREGABALIN
Active strength: 50 mg/1
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50436-1265		D	Discontinued by firm	2026-08-11
excluded package	package	50436-1265	50436-1265-1	D	Discontinued by firm	2026-08-11
excluded package	package	50436-1265	50436-1265-2	D	Discontinued by firm	2026-08-11
excluded package	package	50436-1265	50436-1265-3	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	50436-1265-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-1265-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50436-1265-2	`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	50436-1265-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-1265-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50436-1265-2	`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	50436-1265-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-1265-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50436-1265-2	`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	50436-1265-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-1265-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50436-1265-2	`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	50436-1265-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-1265-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50436-1265-2	`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	50436-1265-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-1265-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50436-1265-2	`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	50436-1265-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-1265-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50436-1265-2	`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	50436-1265-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-1265-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50436-1265-2	`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	50436-1265-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-1265-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50436-1265-2	`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	50436-1265-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-1265-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50436-1265-2	`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	50436-1265-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-1265-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50436-1265-2	`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	50436-1265-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-1265-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50436-1265-2	`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
50436-1265-1	EA - Each	50436-1265	b7ecf6d1-2d5f-4ca4-9e11-0d5fe4fcbbb4	1	2012-07-24
50436-1265-2	EA - Each	50436-1265	a08905e1-acae-4934-806b-79212254e310	1	2012-07-24
50436-1265-3	EA - Each	50436-1265	80a1072e-821e-46fb-ab6d-0e4780a6ace4	1	2012-07-24

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