Pregabalin

Product NDC: 0228-2863
11-digit product format: 002282863
Labeler code: 0228
Product ID: 0228-2863_d5bb20c2-0ad7-4245-a706-4222a5fdf57b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pregabalin
Dosage form: CAPSULE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA091025
Marketing category: ANDA
Marketing start: 2020-10-08
Marketing end: 0000-00-00
Substance: PREGABALIN
Active strength: 300 mg/1
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0228-2863		D	Discontinued by firm		2026-10-15
excluded package	package	0228-2863	0228-2863-09	D	Discontinued by firm		2026-10-15

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 · 4 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	0228-2863-09	`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	0228-2863-09	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A091025-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	2020-07-09
A091025-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	2020-07-09
A091025-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	2020-07-09
A091025-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	2020-07-09
A091025-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	2020-07-09
A091025-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	2020-07-09
A091025-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	2020-07-09
A091025-008	PREGABALIN	PREGABALIN	300MG	CAPSULE / ORAL	2020-07-09

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 8 · 320 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A091025-001	PREGABALIN	25MG	CAPSULE / ORAL	2020-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091025-002	PREGABALIN	50MG	CAPSULE / ORAL	2020-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091025-003	PREGABALIN	75MG	CAPSULE / ORAL	2020-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091025-004	PREGABALIN	100MG	CAPSULE / ORAL	2020-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091025-005	PREGABALIN	150MG	CAPSULE / ORAL	2020-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091025-006	PREGABALIN	200MG	CAPSULE / ORAL	2020-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091025-007	PREGABALIN	225MG	CAPSULE / ORAL	2020-07-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091025-008	PREGABALIN	300MG	CAPSULE / ORAL	2020-07-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091025-001	PREGABALIN	25MG	CAPSULE / ORAL	2020-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091025-002	PREGABALIN	50MG	CAPSULE / ORAL	2020-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091025-003	PREGABALIN	75MG	CAPSULE / ORAL	2020-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091025-004	PREGABALIN	100MG	CAPSULE / ORAL	2020-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091025-005	PREGABALIN	150MG	CAPSULE / ORAL	2020-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091025-006	PREGABALIN	200MG	CAPSULE / ORAL	2020-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091025-007	PREGABALIN	225MG	CAPSULE / ORAL	2020-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091025-008	PREGABALIN	300MG	CAPSULE / ORAL	2020-07-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091025-001	PREGABALIN	25MG	CAPSULE / ORAL	2020-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091025-002	PREGABALIN	50MG	CAPSULE / ORAL	2020-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091025-003	PREGABALIN	75MG	CAPSULE / ORAL	2020-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091025-004	PREGABALIN	100MG	CAPSULE / ORAL	2020-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091025-005	PREGABALIN	150MG	CAPSULE / ORAL	2020-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091025-006	PREGABALIN	200MG	CAPSULE / ORAL	2020-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091025-007	PREGABALIN	225MG	CAPSULE / ORAL	2020-07-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091025-008	PREGABALIN	300MG	CAPSULE / ORAL	2020-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091025-001	PREGABALIN	25MG	CAPSULE / ORAL	2020-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091025-002	PREGABALIN	50MG	CAPSULE / ORAL	2020-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091025-003	PREGABALIN	75MG	CAPSULE / ORAL	2020-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091025-004	PREGABALIN	100MG	CAPSULE / ORAL	2020-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091025-005	PREGABALIN	150MG	CAPSULE / ORAL	2020-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091025-006	PREGABALIN	200MG	CAPSULE / ORAL	2020-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091025-007	PREGABALIN	225MG	CAPSULE / ORAL	2020-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091025-008	PREGABALIN	300MG	CAPSULE / ORAL	2020-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091025-001	PREGABALIN	25MG	CAPSULE / ORAL	2020-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091025-002	PREGABALIN	50MG	CAPSULE / ORAL	2020-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091025-003	PREGABALIN	75MG	CAPSULE / ORAL	2020-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091025-004	PREGABALIN	100MG	CAPSULE / ORAL	2020-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091025-005	PREGABALIN	150MG	CAPSULE / ORAL	2020-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091025-006	PREGABALIN	200MG	CAPSULE / ORAL	2020-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091025-007	PREGABALIN	225MG	CAPSULE / ORAL	2020-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091025-008	PREGABALIN	300MG	CAPSULE / ORAL	2020-07-09	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A091025-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091025-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091025-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091025-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091025-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091025-006	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091025-007	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091025-008	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091025-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091025-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091025-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091025-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091025-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091025-006	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091025-007	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091025-008	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091025-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091025-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091025-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091025-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091025-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091025-006	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091025-007	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091025-008	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091025-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091025-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091025-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091025-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091025-005	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091025-006	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091025-007	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091025-008	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091025-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091025-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091025-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091025-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091025-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091025-006	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091025-007	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091025-008	AB	1	`c0c555d07b60…`

Reported adverse events (FAERS/openFDA)#

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

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
0228-2863-09	00228286309	90 CAPSULE in 1 BOTTLE (0228-2863-09)	90 capsule	2020-10-08	0000-00-00	No	No	Current