PREGABALIN

Product NDC: 61919-503
11-digit product format: 619190503
Labeler code: 61919
Product ID: 61919-503_9cacad08-536a-3517-e053-2a95a90a08dd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREGABALIN
Dosage form: CAPSULE
Route: ORAL
Labeler: DIRECT RX
Application: NDA021446
Marketing category: NDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: PREGABALIN
Active strength: 50 mg/1
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61919-503		I	Inactivated by FDA	2026-10-05
excluded package	package	61919-503	61919-503-60	I	Inactivated by FDA	2026-10-05
excluded package	package	61919-503	61919-503-90	I	Inactivated by FDA	2026-10-05

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	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-503-90	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-503-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-503-90	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-503-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-503-90	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-503-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-503-90	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-503-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-503-90	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-503-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-503-90	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-503-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-503-90	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-503-60	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-503-90	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-503-60	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-503-90	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-503-60	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-503-90	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-503-60	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-503-90	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-503-60	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-503-90	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-503-60	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-503-90	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-503-60	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-503-90	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-503-60	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-503-90	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-503-60	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61919-503-90	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61919-503-60	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-503-60	2023-01-30	C162847	48780-1	f386c64a-08a5-0266-e053-dadaa90a7c1a	PREGABALIN
61919-503-90	2023-01-30	C162847	48780-1	f386c64a-08a5-0266-e053-dadaa90a7c1a	PREGABALIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-503-60	PREGABALIN	60 in 1 BOTTLE	CAPSULE	60		3
61919-503-90	PREGABALIN	90 in 1 BOTTLE	CAPSULE	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-503-60	EA - Each	61919-503	ca9d070b-551a-491c-b42e-d8ccc445a607	1	2014-12-01
61919-503-90	EA - Each	61919-503	371b4015-0a0a-4f90-b91a-02e2f312eb09	1	2014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PREGABALIN	ACTIVE INGREDIENT	55JG375S6M	PREGABALIN CAPSULE [DIRECT RX]	1
PREGABALIN	ACTIVE MOIETY	55JG375S6M	PREGABALIN CAPSULE [DIRECT RX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PREGABALIN CAPSULE [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	PREGABALIN CAPSULE [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PREGABALIN CAPSULE [DIRECT RX]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	PREGABALIN CAPSULE [DIRECT RX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PREGABALIN CAPSULE [DIRECT RX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PREGABALIN CAPSULE [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PREGABALIN CAPSULE [DIRECT RX]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PREGABALIN CAPSULE [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PREGABALIN CAPSULE [DIRECT RX]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PREGABALIN CAPSULE [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PREGABALIN CAPSULE [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-503	PREGABALIN CAPSULE [DIRECT RX]	3	Legacy NDC, 2 package rows	20200130_54e6d137-a495-4b87-b3c2-2f5a0226dd3e.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
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
483448	pregabalin 50 MG Oral Capsule	PSN	54e6d137-a495-4b87-b3c2-2f5a0226dd3e	3
483448	pregabalin 50 MG Oral Capsule	SCD	54e6d137-a495-4b87-b3c2-2f5a0226dd3e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-503-60	61919050360	60 CAPSULE in 1 BOTTLE (61919-503-60)	60 capsule	2015-01-01	0000-00-00	No	No	Current
61919-503-90	61919050390	90 CAPSULE in 1 BOTTLE (61919-503-90)	90 capsule	2015-01-01	0000-00-00	No	No	Current