Pregabalin

Product NDC: 51407-511
11-digit product format: 514070511
Labeler code: 51407
Product ID: 51407-511_cf46e2e2-9143-ee33-e053-2a95a90a219f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREGABALIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA208677
Marketing category: ANDA
Marketing start: 2019-07-19
Marketing end: 0000-00-00
Substance: PREGABALIN
Active strength: 75 mg/1
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2022-12-31
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	51407-511		D	Discontinued by firm		2026-10-05
excluded package	package	51407-511	51407-511-90	D	Discontinued by firm		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 · 24 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	51407-511-90	`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	51407-511-90	`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	51407-511-90	`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	51407-511-90	`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	51407-511-90	`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	51407-511-90	`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	51407-511-90	`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	51407-511-90	`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	51407-511-90	`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	51407-511-90	`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	51407-511-90	`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	51407-511-90	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	Approval date
A208677-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19
A208677-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19
A208677-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19
A208677-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19
A208677-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19
A208677-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19
A208677-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19
A208677-008	PREGABALIN	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208677-001	AB
A208677-002	AB
A208677-003	AB
A208677-004	AB
A208677-005	AB
A208677-006	AB
A208677-007	AB
A208677-008	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 · 336 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
2026-09-14 22:38:34	2026-08	A208677-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208677-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208677-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208677-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`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	A208677-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-008	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208677-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208677-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208677-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-008	AB	1	`6a471c1ec25d…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-511-90	EA - Each	51407-511	5ced80a5-dda7-44c5-99ef-a3f236f36915	1	2019-08-06

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 2 of 5 · 87 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Bryant Ranch Prepack	c60f6b1e-7a24-41b2-8435-e20583a732c6	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	52e36f66-4c4a-4fc5-968b-46879b7bf1db	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	df382975-73f1-4957-8959-177848f796f7	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	90b65884-4222-4011-b042-88b83e51c57a	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	dbf3647a-5ab1-450e-be5f-69b844185572	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	be8d51d7-ae26-4fc7-9457-a4ad84523fd7	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	9053ff4e-cc47-4fa8-990a-4b0d539a480a	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	36085f4e-91ae-458c-b0a0-81363112df01	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	47cc53e6-e679-4a01-babc-af301dd756f7	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	4db38263-899a-8405-e063-6294a90a4408	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	4ddf514f-3922-624b-e063-6394a90a8f6b	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	4ddf7b9b-7b72-913c-e063-6394a90af3a4	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	4db84135-4e89-0f23-e063-6394a90a9b9b	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	A-S Medication Solutions	55b62778-0e6a-45e8-9ace-3f1d6eca4487	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	99c3d252-4d51-4679-aa61-e2d0b8238b38	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Golden State Medical Supply, Inc.	1ef735e8-467e-ed0d-e063-6294a90a210e	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	ScieGen Pharmaceuticals, Inc	459f0d31-a73f-2c62-e063-6394a90a810c	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	14c00449-c3b8-d6ba-e063-6294a90ab627	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	ScieGen Pharmaceuticals, Inc	33ef1a3b-554f-4a51-afdb-92a019e8c16c	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Westminster Pharmaceuticals, LLC	781cb1ac-a0d2-4b47-b319-f0b90de86384	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677

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	f33a9245-8a54-4d1c-8fbd-e00194fa9c93	1
483440	pregabalin 150 MG Oral Capsule	PSN	f33a9245-8a54-4d1c-8fbd-e00194fa9c93	1
483446	pregabalin 200 MG Oral Capsule	PSN	f33a9245-8a54-4d1c-8fbd-e00194fa9c93	1
577127	pregabalin 225 MG Oral Capsule	PSN	f33a9245-8a54-4d1c-8fbd-e00194fa9c93	1
483442	pregabalin 25 MG Oral Capsule	PSN	f33a9245-8a54-4d1c-8fbd-e00194fa9c93	1
483444	pregabalin 300 MG Oral Capsule	PSN	f33a9245-8a54-4d1c-8fbd-e00194fa9c93	1
483448	pregabalin 50 MG Oral Capsule	PSN	f33a9245-8a54-4d1c-8fbd-e00194fa9c93	1
483450	pregabalin 75 MG Oral Capsule	PSN	f33a9245-8a54-4d1c-8fbd-e00194fa9c93	1
483438	pregabalin 100 MG Oral Capsule	SCD	f33a9245-8a54-4d1c-8fbd-e00194fa9c93	1
483440	pregabalin 150 MG Oral Capsule	SCD	f33a9245-8a54-4d1c-8fbd-e00194fa9c93	1
483446	pregabalin 200 MG Oral Capsule	SCD	f33a9245-8a54-4d1c-8fbd-e00194fa9c93	1
577127	pregabalin 225 MG Oral Capsule	SCD	f33a9245-8a54-4d1c-8fbd-e00194fa9c93	1
483442	pregabalin 25 MG Oral Capsule	SCD	f33a9245-8a54-4d1c-8fbd-e00194fa9c93	1
483444	pregabalin 300 MG Oral Capsule	SCD	f33a9245-8a54-4d1c-8fbd-e00194fa9c93	1
483448	pregabalin 50 MG Oral Capsule	SCD	f33a9245-8a54-4d1c-8fbd-e00194fa9c93	1
483450	pregabalin 75 MG Oral Capsule	SCD	f33a9245-8a54-4d1c-8fbd-e00194fa9c93	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51407-511-90	51407051190	90 CAPSULE in 1 BOTTLE (51407-511-90)	90 capsule	2019-07-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pregabalin - Golden State Medical Supply, Inc. \| ScieGen Pharmaceuticals, Inc	Golden State Medical Supply, Inc. \| ScieGen Pharmaceuticals, Inc	2021-10-26	HUMAN PRESCRIPTION DRUG LABEL	3
Pregabalin - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2019-08-27	HUMAN PRESCRIPTION DRUG LABEL	1