PREGABALIN

Product NDC: 75834-297
11-digit product format: 758340297
Labeler code: 75834
Product ID: 75834-297_3b93005b-dd76-4271-9b3c-f2f047285f13
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREGABALIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Nivagen Pharmaceuticals, Inc.
Application: ANDA212988
Marketing category: ANDA
Marketing start: 2022-07-14
Marketing end: 0000-00-00
Substance: PREGABALIN
Active strength: 50 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	75834-297		I	Inactivated by FDA	2026-08-10
excluded package	package	75834-297	75834-297-05	I	Inactivated by FDA	2026-08-10
excluded package	package	75834-297	75834-297-60	I	Inactivated by FDA	2026-08-10
excluded package	package	75834-297	75834-297-90	I	Inactivated by FDA	2026-08-10

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	Approval date
A212988-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	AB	2022-03-08
A212988-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	AB	2022-03-08
A212988-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	AB	2022-03-08
A212988-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	AB	2022-03-08
A212988-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	AB	2022-03-08
A212988-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	AB	2022-03-08
A212988-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	AB	2022-03-08
A212988-008	PREGABALIN	PREGABALIN	300MG	CAPSULE / ORAL	AB	2022-03-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212988-001	AB
A212988-002	AB
A212988-003	AB
A212988-004	AB
A212988-005	AB
A212988-006	AB
A212988-007	AB
A212988-008	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 7 · 248 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212988-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2022-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2022-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2022-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2022-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2022-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2022-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2022-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2022-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2022-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2022-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2022-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2022-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2022-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2022-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2022-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2022-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212988-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2022-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2022-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2022-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2022-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2022-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2022-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2022-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2022-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2022-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2022-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2022-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2022-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2022-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2022-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2022-03-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2022-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2022-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2022-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2022-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2022-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2022-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2022-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2022-03-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2022-03-08	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 248 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	A212988-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212988-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212988-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212988-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212988-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212988-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212988-008	AB	1	`b8a1b40f171c…`

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
75834-297-05	2026-01-29	C162847	48780-1	49896155-ac09-586f-e063-e6dba90add90	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
75834-297-60	2026-01-29	C162847	48780-1	49896155-ac09-586f-e063-e6dba90add90	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
75834-297-90	2026-01-29	C162847	48780-1	49896155-ac09-586f-e063-e6dba90add90	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
75834-297-05	PREGABALIN	500 in 1 BOTTLE	CAPSULE	500	1
75834-297-60	PREGABALIN	60 in 1 BOTTLE	CAPSULE	60	1
75834-297-90	PREGABALIN	90 in 1 BOTTLE	CAPSULE	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75834-297	PREGABALIN CAPSULE [NIVAGEN PHARMACEUTICALS, INC.]	1	Legacy NDC, 3 package rows	20220728_388369d9-c76f-431f-89cc-20b39dd73bc3.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Proficient Rx LP	189b610e-3e29-42fa-ab6e-73effbe0d054	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212988 application number: ANDA212988
Pregabalin	PREGABALIN	Proficient Rx LP	34846423-e747-42c5-9bcd-f99c557c4f67	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212988 application number: ANDA212988
PREGABALIN	PREGABALIN	Eskayef Pharmaceuticals Limited	65d9e751-61c2-4741-85c0-2526cfdc765c	2025-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212988 application number: ANDA212988
Pregabalin	PREGABALIN	AvKARE	458705af-06fa-57d1-e063-6394a90a3b2e	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212988 application number: ANDA212988
Pregabalin	PREGABALIN	Westminster Pharmaceuticals, LLC	6b0ee2cf-52c3-4052-bea0-1458a4233745	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212988 application number: ANDA212988

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
483438	pregabalin 100 MG Oral Capsule	PSN	388369d9-c76f-431f-89cc-20b39dd73bc3	1
483440	pregabalin 150 MG Oral Capsule	PSN	388369d9-c76f-431f-89cc-20b39dd73bc3	1
483446	pregabalin 200 MG Oral Capsule	PSN	388369d9-c76f-431f-89cc-20b39dd73bc3	1
577127	pregabalin 225 MG Oral Capsule	PSN	388369d9-c76f-431f-89cc-20b39dd73bc3	1
483442	pregabalin 25 MG Oral Capsule	PSN	388369d9-c76f-431f-89cc-20b39dd73bc3	1
483444	pregabalin 300 MG Oral Capsule	PSN	388369d9-c76f-431f-89cc-20b39dd73bc3	1
483448	pregabalin 50 MG Oral Capsule	PSN	388369d9-c76f-431f-89cc-20b39dd73bc3	1
483450	pregabalin 75 MG Oral Capsule	PSN	388369d9-c76f-431f-89cc-20b39dd73bc3	1
483438	pregabalin 100 MG Oral Capsule	SCD	388369d9-c76f-431f-89cc-20b39dd73bc3	1
483440	pregabalin 150 MG Oral Capsule	SCD	388369d9-c76f-431f-89cc-20b39dd73bc3	1
483446	pregabalin 200 MG Oral Capsule	SCD	388369d9-c76f-431f-89cc-20b39dd73bc3	1
577127	pregabalin 225 MG Oral Capsule	SCD	388369d9-c76f-431f-89cc-20b39dd73bc3	1
483442	pregabalin 25 MG Oral Capsule	SCD	388369d9-c76f-431f-89cc-20b39dd73bc3	1
483444	pregabalin 300 MG Oral Capsule	SCD	388369d9-c76f-431f-89cc-20b39dd73bc3	1
483448	pregabalin 50 MG Oral Capsule	SCD	388369d9-c76f-431f-89cc-20b39dd73bc3	1
483450	pregabalin 75 MG Oral Capsule	SCD	388369d9-c76f-431f-89cc-20b39dd73bc3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75834-297-05	75834029705	500 CAPSULE in 1 BOTTLE (75834-297-05)	500 capsule	2022-07-14	0000-00-00	No	No	Current
75834-297-60	75834029760	60 CAPSULE in 1 BOTTLE (75834-297-60)	60 capsule	2022-07-14	0000-00-00	No	No	Current
75834-297-90	75834029790	90 CAPSULE in 1 BOTTLE (75834-297-90)	90 capsule	2022-07-14	0000-00-00	No	No	Current