Pregabalin

Product NDC: 70518-4585
11-digit product format: 705184585
Labeler code: 70518
Product ID: 70518-4585_4cec8699-7b8d-a64f-e063-6394a90ac5b4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pregabalin
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA206912
Marketing category: ANDA
Marketing start: 2026-03-13
Substance: PREGABALIN
Active strength: 50 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 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
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 8 · 312 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	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…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206912-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206912-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206912-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206912-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206912-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206912-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206912-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206912-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206912-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206912-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206912-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206912-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206912-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206912-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206912-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206912-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-10-08	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 312 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	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…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206912-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206912-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206912-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206912-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206912-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206912-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206912-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206912-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206912-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206912-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206912-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206912-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206912-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206912-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206912-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206912-008	AB	1	`b8a1b40f171c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pregabalin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PREGABALIN	50 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
483448	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
c60752f8-20d5-4333-bf33-a656eab01d6b	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
70518-4585-0	Pregabalin	90 in 1 BOTTLE, PLASTIC	CAPSULE	90		1

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 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Bryant Ranch Prepack	1e6fa742-f658-495f-88bb-8eddf9a45ffe	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912
Pregabalin	PREGABALIN	Bryant Ranch Prepack	48798c13-3ef4-4e7f-9f73-92dccac0af14	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912
Pregabalin	PREGABALIN	St. Mary's Medical Park Pharmacy	2c62e63a-fe81-a463-e063-6394a90a65ee	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912
Pregabalin	PREGABALIN	A-S Medication Solutions	b740832a-6e90-4b20-bfed-be0415f1aebe	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912
Pregabalin	PREGABALIN	Proficient Rx LP	efc36145-fffd-44de-9a42-f277d0ff39c9	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912
Pregabalin	PREGABALIN	REMEDYREPACK INC.	c60752f8-20d5-4333-bf33-a656eab01d6b	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912 ndc (product): 70518-4585
Pregabalin	PREGABALIN	NorthStar RxLLC	4a4d4c76-31c5-413b-be7c-82cb8091c19d	2025-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912
Pregabalin	PREGABALIN	REMEDYREPACK INC.	e897d7e8-2743-4512-8417-375cb11ceec6	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912
Pregabalin	PREGABALIN	Camber Pharmaceuticals, Inc.	241c4b7e-f719-4828-8639-ea613b8a6583	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912
Pregabalin	PREGABALIN	Preferred Pharmaceuticals Inc.	dc50f01d-1802-4666-8f2f-35980a40990f	2025-09-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912
Pregabalin	PREGABALIN	Preferred Pharmaceuticals Inc.	7f29991e-3bf5-4e48-8fa3-6d4e932ed6de	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912
Pregabalin	PREGABALIN	Proficient Rx LP	a025e4fc-e0c1-4c5b-a1c8-bd8e578a737e	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912
Pregabalin	PREGABALIN	Proficient Rx LP	2b87989d-6411-4996-8f05-05806ab80525	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	d28168cd-9b7a-f8df-e053-2995a90ad97f	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	c6b456ca-9d07-7789-e053-2a95a90a20c5	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	c8bfc4f9-6208-4eaa-e053-2a95a90ada97	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206912 application number: ANDA206912
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

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
483448	pregabalin 50 MG Oral Capsule	PSN	c60752f8-20d5-4333-bf33-a656eab01d6b	1
483448	pregabalin 50 MG Oral Capsule	SCD	c60752f8-20d5-4333-bf33-a656eab01d6b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4585-0	70518458500	90 CAPSULE in 1 BOTTLE, PLASTIC (70518-4585-0)	90 capsule	2026-03-13	No	No	Current
70518-4585-1	70518458501	30 CAPSULE in 1 BLISTER PACK (70518-4585-1)	30 capsule	2026-08-03	0		Current