Pregabalin

Product NDC: 80425-0029
11-digit product format: 804250029
Labeler code: 80425
Product ID: 80425-0029_2a984dd9-7294-77f0-e063-6294a90a8f1e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pregabalin
Dosage form: CAPSULE
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA209743
Marketing category: ANDA
Marketing start: 2019-07-19
Substance: PREGABALIN
Active strength: 75 mg/1
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A209743-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19
A209743-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19
A209743-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19
A209743-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19
A209743-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19
A209743-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19
A209743-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19
A209743-008	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
A209743-001	AB
A209743-002	AB
A209743-003	AB
A209743-004	AB
A209743-005	AB
A209743-006	AB
A209743-007	AB
A209743-008	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 8 · 320 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	A209743-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209743-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209743-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209743-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209743-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209743-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209743-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209743-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209743-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209743-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`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	A209743-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209743-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209743-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209743-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209743-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209743-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209743-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209743-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209743-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209743-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209743-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209743-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209743-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209743-008	AB	1	`b8a1b40f171c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pregabalin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREGABALIN	75 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
55JG375S6M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
483450	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
afc89ca3-5597-1c75-e053-2a95a90a3ff2	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80425-0029-1	Pregabalin	60 in 1 BOTTLE	CAPSULE	60	7
80425-0029-2	Pregabalin	90 in 1 BOTTLE	CAPSULE	90	7
80425-0029-3	Pregabalin	30 in 1 BOTTLE	CAPSULE	30	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0029-1	EA - Each	80425-0029	0511c5d5-7ea6-4a47-8714-e802f6cb8c70	1	2023-04-07
80425-0029-2	EA - Each	80425-0029	b4269445-5768-4e24-974e-62210b5bfebc	1	2023-04-07
80425-0029-3	EA - Each	80425-0029	3d5cd76c-f0f1-4d7a-bb72-89f4ad3b0736	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0029	PREGABALIN CAPSULE [ADVANCED RX OF TENNESSEE, LLC]	7	Current NDC, Legacy NDC, 3 package rows	20250101_afc89ca3-5597-1c75-e053-2a95a90a3ff2.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	REMEDYREPACK INC.	d095accf-9cea-4948-b43d-ae1b8fbce7c2	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209743 application number: ANDA209743
Pregabalin	PREGABALIN	Amneal Pharmaceuticals NY LLC	3d9d7123-5886-4b61-a7ea-471b213e77d9	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209743 application number: ANDA209743
Pregabalin	PREGABALIN	Amneal Pharmaceuticals NY LLC	3099759f-cb24-40e8-b482-9388c38c73b9	2025-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209743 application number: ANDA209743
PREGABALIN	PREGABALIN	Direct_Rx	91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209743 application number: ANDA209743
Pregabalin	PREGABALIN	Advanced Rx of Tennessee, LLC	afc89ca3-5597-1c75-e053-2a95a90a3ff2	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209743 application number: ANDA209743 ndc (product): 80425-0029
Pregabalin	PREGABALIN	Advanced Rx of Tennessee, LLC	af739a0d-a3cd-754f-e053-2a95a90ad655	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209743 application number: ANDA209743
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	b8172d6b-a646-e559-e053-2a95a90ac24d	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209743 application number: ANDA209743
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	bc1b143d-feaf-9498-e053-2995a90acf50	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209743 application number: ANDA209743
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	b817083c-b535-2269-e053-2a95a90af5b9	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209743 application number: ANDA209743
Pregabalin	PREGABALIN	Proficient Rx LP	a17f03ea-9375-48fe-be32-f8df509f5fba	2023-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209743 application number: ANDA209743

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
483450	pregabalin 75 MG Oral Capsule	PSN	afc89ca3-5597-1c75-e053-2a95a90a3ff2	7
483450	pregabalin 75 MG Oral Capsule	SCD	afc89ca3-5597-1c75-e053-2a95a90a3ff2	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80425-0029-1	80425002901	60 CAPSULE in 1 BOTTLE (80425-0029-1)	60 capsule	2019-07-19	0000-00-00	No	No	Current
80425-0029-2	80425002902	90 CAPSULE in 1 BOTTLE (80425-0029-2)	90 capsule	2019-07-19	0000-00-00	No	No	Current
80425-0029-3	80425002903	30 CAPSULE in 1 BOTTLE (80425-0029-3)	30 capsule	2019-07-19		No	No	Current