Pregabalin

Product NDC: 68788-7520
11-digit product format: 687887520
Labeler code: 68788
Product ID: 68788-7520_832a4707-4116-4a21-b6cc-28e5492c79bb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREGABALIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA208677
Marketing category: ANDA
Marketing start: 2019-07-19
Substance: PREGABALIN
Active strength: 25 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 44.

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
A208677-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19
A208677-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19
A208677-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19
A208677-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19
A208677-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19
A208677-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19
A208677-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19
A208677-008	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
A208677-001	AB
A208677-002	AB
A208677-003	AB
A208677-004	AB
A208677-005	AB
A208677-006	AB
A208677-007	AB
A208677-008	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 · 344 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
2026-10-15 13:18:30	2026-09	A208677-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208677-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208677-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208677-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208677-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208677-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208677-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208677-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208677-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208677-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208677-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 344 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A208677-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208677-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208677-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208677-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208677-005	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208677-006	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208677-007	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208677-008	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208677-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208677-008	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208677-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208677-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208677-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208677-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208677-008	AB	1	`31067a03dcf5…`

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	25 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
483442	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
ce1419bc-c348-4407-b320-e0598d5a7b19	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68788-7520-1	2022-02-14	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-1	2022-02-14	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-3	2022-02-14	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-3	2022-02-14	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-6	2022-02-14	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-6	2022-02-14	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-9	2022-02-14	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-9	2022-02-14	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-1	2022-01-28	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-1	2022-01-28	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-3	2022-01-28	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-3	2022-01-28	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-6	2022-01-28	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-6	2022-01-28	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-9	2022-01-28	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-9	2022-01-28	These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-7520-1	Pregabalin	100 in 1 BOTTLE	CAPSULE	100	6
68788-7520-3	Pregabalin	30 in 1 BOTTLE	CAPSULE	30	6
68788-7520-6	Pregabalin	60 in 1 BOTTLE	CAPSULE	60	6
68788-7520-9	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
68788-7520-1	EA - Each	68788-7520	e76b83cd-81e7-46f9-8bc2-941defaf86d9	1	2019-11-12
68788-7520-3	EA - Each	68788-7520	c77e437b-f000-4937-9206-fd133b14d229	1	2019-11-12
68788-7520-6	EA - Each	68788-7520	03db85e4-c61e-4472-86ca-f5bf23d2719e	1	2019-11-12
68788-7520-9	EA - Each	68788-7520	cd990bf0-bb1b-4749-8a1f-650b1f59905e	1	2019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7520	PREGABALIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 4 package rows	20240802_ce1419bc-c348-4407-b320-e0598d5a7b19.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 5 of 5 · 87 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Asclemed USA, Inc.	3d2464fb-b3ac-496e-b8a5-c2e8a902ce29	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Proficient Rx LP	65311ae9-e440-4650-b1b1-6f4495fda93c	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Proficient Rx LP	c7986739-3fc9-4a1d-8dd6-2e11cf1f3610	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Proficient Rx LP	89b8c2d2-4a99-4b97-8b82-c0c36cd0df1b	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Proficient Rx LP	9b1472ac-8b79-4f22-ae50-3b0942bd62b1	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Proficient Rx LP	d58c0808-2ff9-4ce6-9c07-56f723592385	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Proficient Rx LP	a0f2b8af-0a04-4db0-adb3-d9d9369223d9	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677

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
483442	pregabalin 25 MG Oral Capsule	PSN	ce1419bc-c348-4407-b320-e0598d5a7b19	6
483442	pregabalin 25 MG Oral Capsule	SCD	ce1419bc-c348-4407-b320-e0598d5a7b19	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7520-1	68788752001	100 CAPSULE in 1 BOTTLE (68788-7520-1)	100 capsule	2019-10-28	0000-00-00	No	No	Current
68788-7520-3	68788752003	30 CAPSULE in 1 BOTTLE (68788-7520-3)	30 capsule	2019-10-28	0000-00-00	No	No	Current
68788-7520-6	68788752006	60 CAPSULE in 1 BOTTLE (68788-7520-6)	60 capsule	2019-10-28	0000-00-00	No	No	Current
68788-7520-9	68788752009	90 CAPSULE in 1 BOTTLE (68788-7520-9)	90 capsule	2019-10-28	0000-00-00	No	No	Current