Pregabalin

Product NDC: 80425-0160
11-digit product format: 804250160
Labeler code: 80425
Product ID: 80425-0160_2a99c981-daee-71e5-e063-6294a90a5c1d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pregabalin
Dosage form: CAPSULE
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA207799
Marketing category: ANDA
Marketing start: 2019-07-21
Substance: PREGABALIN
Active strength: 300 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 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
A207799-001	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19
A207799-002	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19
A207799-003	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19
A207799-004	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19
A207799-005	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19
A207799-006	PREGABALIN	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19
A207799-007	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-09-30
A207799-008	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207799-001	AB
A207799-002	AB
A207799-003	AB
A207799-004	AB
A207799-005	AB
A207799-006	AB
A207799-007	AB
A207799-008	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 · 324 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	A207799-001	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-002	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-003	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-004	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-005	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-006	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-007	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-008	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-09-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207799-001	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-002	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-003	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-004	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-005	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-006	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-007	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-008	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-09-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207799-001	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-002	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-003	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-004	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-005	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-006	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-007	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-008	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-001	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-002	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-003	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-004	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-005	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-006	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-007	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-008	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207799-001	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-002	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-003	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-004	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-005	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-006	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-007	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-008	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-09-30	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 324 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	A207799-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207799-008	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207799-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207799-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207799-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207799-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207799-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207799-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207799-008	AB	1	`6a471c1ec25d…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREGABALIN	300 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
483444	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
c89a3514-f637-e54f-e053-2a95a90a6881	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
80425-0160-3	Pregabalin	90 in 1 BOTTLE	CAPSULE	90		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0160-3	EA - Each	80425-0160	1778b494-23ea-4e4b-91a1-3f29d62313c6	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0160	PREGABALIN CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	6	Current NDC, Legacy NDC, 1 package rows	20250101_c89a3514-f637-e54f-e053-2a95a90a6881.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.	ab06a36d-9a2d-4eae-8991-4eab5bc8311c	2026-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799
Pregabalin	PREGABALIN	REMEDYREPACK INC.	12309847-0857-4ff7-a7e7-edeadc3dfb61	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799
Pregabalin	PREGABALIN	REMEDYREPACK INC.	47d08b8f-a24d-4159-ab43-2eb67a93559b	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799
Pregabalin	PREGABALIN	REMEDYREPACK INC.	3c8ea6da-5771-4096-a915-700e51ced05c	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799
Pregabalin	PREGABALIN	REMEDYREPACK INC.	9c38abbc-2b3d-48d6-b629-4a163c803db5	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799
Pregabalin	PREGABALIN	REMEDYREPACK INC.	efe06a26-30c5-437d-9fd1-4bd0062f1200	2026-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799
Pregabalin	PREGABALIN	Ascend Laboratories, LLC	e48db3c2-7351-41f2-a451-5a8341c4125c	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799
Pregabalin	PREGABALIN	St. Mary's Medical Park Pharmacy	35d3486c-c6ea-4d31-e063-6294a90a1219	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799
Pregabalin	PREGABALIN	St. Mary's Medical Park Pharmacy	35d387dd-bc7f-37a4-e063-6394a90abbbb	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799
Pregabalin	PREGABALIN	Clinical Solutions Wholesale, LLC	150c8b71-98b0-4c6b-b20f-fd0fca2d3c26	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799
Pregabalin	PREGABALIN	ST. MARY'S MEDICAL PARK PHARMACY	3dd7930b-f544-f18b-e063-6294a90a0541	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799
Pregabalin	PREGABALIN	Clinical Solutions Wholesale, LLC	613a7a13-d5ba-4827-91ec-3ed5176602b7	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799
Pregabalin	PREGABALIN	Bryant Ranch Prepack	b5b22ec1-3fd8-4631-ba7e-98d8e5d030b3	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799
Pregabalin	PREGABALIN	Preferred Pharmaceuticals Inc.	e8e272a4-c181-4573-822b-2bb315b6ad37	2025-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799
Pregabalin	PREGABALIN	Preferred Pharmaceuticals Inc.	a0da0534-b386-4c93-ae89-03b0e3325e02	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	c89a3514-f637-e54f-e053-2a95a90a6881	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799 ndc (product): 80425-0160
PREGABALIN	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	d2813712-d7f6-6144-e053-2995a90a3c5d	2024-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799
Pregabalin	PREGABALIN	Bryant Ranch Prepack	4cda70e8-9ae1-4958-8c86-1bc633be982b	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799
Pregabalin	PREGABALIN	Bryant Ranch Prepack	cf7f0fd0-bac2-4836-9363-79d32ad0cc10	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799
Pregabalin	PREGABALIN	Bryant Ranch Prepack	08ad87e3-e00c-46d1-98f8-df493cf1712e	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207799 application number: ANDA207799

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
483444	pregabalin 300 MG Oral Capsule	PSN	c89a3514-f637-e54f-e053-2a95a90a6881	6
483444	pregabalin 300 MG Oral Capsule	SCD	c89a3514-f637-e54f-e053-2a95a90a6881	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80425-0160-3	80425016003	90 CAPSULE in 1 BOTTLE (80425-0160-3)	90 capsule	2019-07-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pregabalin Capsules	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	6