Pregabalin

Product NDC: 82804-170
11-digit product format: 828040170
Labeler code: 82804
Product ID: 82804-170_e80b626b-701e-4b20-a6b3-77b064c8d495
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pregabalin
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA206912
Marketing category: ANDA
Marketing start: 2019-10-08
Substance: PREGABALIN
Active strength: 75 mg/1
DEA schedule: CV
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A206912-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-10-08
A206912-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-10-08
A206912-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-10-08
A206912-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-10-08
A206912-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-10-08
A206912-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-10-08
A206912-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-10-08
A206912-008	PREGABALIN	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206912-001	AB
A206912-002	AB
A206912-003	AB
A206912-004	AB
A206912-005	AB
A206912-006	AB
A206912-007	AB
A206912-008	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 · 328 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	A206912-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-10-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206912-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206912-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206912-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-10-08	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 328 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	A206912-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206912-008	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206912-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206912-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206912-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206912-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206912-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206912-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206912-008	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: 2027-12-31

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
a025e4fc-e0c1-4c5b-a1c8-bd8e578a737e	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
82804-170-60	Pregabalin	60 in 1 BOTTLE	CAPSULE	60		2
82804-170-90	Pregabalin	90 in 1 BOTTLE	CAPSULE	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82804-170-60	EA - Each	82804-170	08df1fd4-4511-428e-82a6-aaf0f0e7f9d1	1	2025-03-04
82804-170-90	EA - Each	82804-170	15f1c437-3300-469d-af08-652fef664399	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82804-170	PREGABALIN CAPSULE [PROFICIENT RX LP]	2	Current NDC, 2 package rows	20250331_a025e4fc-e0c1-4c5b-a1c8-bd8e578a737e.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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	c8acdbcf-3076-63b2-e053-2a95a90aa3c4	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912
Pregabalin	PREGABALIN	Bryant Ranch Prepack	fac0eb4e-12ef-4e8e-8cbe-c43c26f0faee	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912
Pregabalin	PREGABALIN	Bryant Ranch Prepack	c72b0bed-b7b4-4ae1-914e-756d76b66ed9	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912
Pregabalin	PREGABALIN	Bryant Ranch Prepack	aac1f2f4-5ef5-49dd-b914-54f2cf2b1bc1	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912
Pregabalin	PREGABALIN	Bryant Ranch Prepack	b2d45d41-a787-4912-962d-0bd98b70d58a	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912
Pregabalin	PREGABALIN	Bryant Ranch Prepack	616b37d6-93d5-44de-a993-bddf59eaee9a	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912

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	a025e4fc-e0c1-4c5b-a1c8-bd8e578a737e	2
483450	pregabalin 75 MG Oral Capsule	SCD	a025e4fc-e0c1-4c5b-a1c8-bd8e578a737e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82804-170-60	82804017060	60 CAPSULE in 1 BOTTLE (82804-170-60)	60 capsule	2024-12-03	No	No	Current
82804-170-90	82804017090	90 CAPSULE in 1 BOTTLE (82804-170-90)	90 capsule	2025-03-26	No	No	Current