Pregabalin

Product NDC: 80425-0030
11-digit product format: 804250030
Labeler code: 80425
Product ID: 80425-0030_43ccc5cb-7aee-4ee0-e063-6294a90af140
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pregabalin
Dosage form: CAPSULE
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA209357
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
A209357-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19
A209357-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19
A209357-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19
A209357-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19
A209357-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19
A209357-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19
A209357-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19
A209357-008	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
A209357-001	AB
A209357-002	AB
A209357-003	AB
A209357-004	AB
A209357-005	AB
A209357-006	AB
A209357-007	AB
A209357-008	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	A209357-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209357-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209357-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209357-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209357-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209357-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209357-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209357-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209357-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209357-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209357-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209357-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209357-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209357-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209357-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209357-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209357-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209357-008	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	A209357-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209357-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209357-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209357-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209357-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209357-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209357-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209357-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209357-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209357-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209357-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209357-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209357-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209357-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209357-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209357-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209357-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209357-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209357-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209357-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209357-008	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
afc89689-bea9-92ec-e053-2995a90a7f21	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	Strength	SPL version
80425-0030-1	Pregabalin	60 in 1 BOTTLE	CAPSULE	60		7
80425-0030-2	Pregabalin	90 in 1 BOTTLE	CAPSULE	90		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0030-1	EA - Each	80425-0030	6d24910f-7f13-4a9b-9add-abcb3d5bf6bf	1	2023-04-07
80425-0030-2	EA - Each	80425-0030	d14237e9-9109-400a-9074-772dc5d6d057	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0030	PREGABALIN CAPSULE [ADVANCED RX OF TENNESSEE, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20250101_afc89689-bea9-92ec-e053-2995a90a7f21.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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	REMEDYREPACK INC.	f30a7a3b-d45e-4e0b-ab1b-1369b2f02320	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	REMEDYREPACK INC.	326c643a-23c5-4dab-9266-abc22ca1f874	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	REMEDYREPACK INC.	91edbe87-cd22-43a5-9952-1cd523b13820	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	REMEDYREPACK INC.	14f3f9ba-7a4a-45d5-a25e-efe5cdff117d	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	REMEDYREPACK INC.	44ec2918-4e0c-4e2d-9157-81295a15df57	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	St. Mary's Medical Park Pharmacy	36c3dda1-67fb-4dc5-e063-6294a90a1c3e	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	St. Mary's Medical Park Pharmacy	2e6e6f9c-a14c-2d75-e063-6294a90a827e	2026-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	REMEDYREPACK INC.	ba3006b7-991f-4ae0-b908-5910e827e5bf	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	REMEDYREPACK INC.	5290f7ad-6660-45ff-853d-6dcb947b570d	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	ST. MARY'S MEDICAL PARK PHARMACY	4b94bfc1-88fc-2b5f-e063-6394a90a7077	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	A-S Medication Solutions	217c9f93-fe89-4684-8553-12ec9acaa507	2026-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	A-S Medication Solutions	5d33e9c7-6d81-485b-bf4a-9a588eda5208	2026-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	A-S Medication Solutions	fa24fa02-e27d-476a-b6c4-93650aaaee68	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	Advanced Rx of Tennessee, LLC	afc89689-bea9-92ec-e053-2995a90a7f21	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357 ndc (product): 80425-0030
Pregabalin	PREGABALIN	AvPAK	40c0f658-2a0a-034b-e063-6394a90a1097	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	Proficient Rx LP	7d25bec8-b503-4f63-8995-372a6df58c72	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	Novadoz Pharmaceuticals LLC	193666f7-3c55-43b1-947a-2ffec40c687f	2025-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	b1f4b888-ac88-4250-8db1-706e7cc01e93	2025-03-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	b0f34220-0657-4868-ae01-014f9300f622	2025-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357
Pregabalin	PREGABALIN	Proficient Rx LP	580955ba-86f6-4e86-b0fa-dd44e8828b0e	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209357 application number: ANDA209357

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	afc89689-bea9-92ec-e053-2995a90a7f21	7
483450	pregabalin 75 MG Oral Capsule	SCD	afc89689-bea9-92ec-e053-2995a90a7f21	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80425-0030-1	80425003001	60 CAPSULE in 1 BOTTLE (80425-0030-1)	60 capsule	2019-07-19	0000-00-00	No	No	Current
80425-0030-2	80425003002	90 CAPSULE in 1 BOTTLE (80425-0030-2)	90 capsule	2019-07-19	0000-00-00	No	No	Current