Pregabalin

Product NDC: 71610-930
11-digit product format: 716100930
Labeler code: 71610
Product ID: 71610-930_3ab511fe-2be7-d9fd-e063-6394a90ad973
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pregabalin
Dosage form: CAPSULE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA208677
Marketing category: ANDA
Marketing start: 2021-08-24
Substance: PREGABALIN
Active strength: 50 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
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 · 336 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	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…`
2025-08-23 18:47 UTC	2025-08	A208677-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 336 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	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…`
2025-08-23 18:47 UTC	2025-08	A208677-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208677-008	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	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
3ab4efb3-1ae5-2504-e063-6294a90a6d1d	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	SPL version
71610-930-30	Pregabalin	30 in 1 BOTTLE	CAPSULE	30	1
71610-930-46	Pregabalin	56 in 1 BOTTLE	CAPSULE	56	1
71610-930-53	Pregabalin	60 in 1 BOTTLE	CAPSULE	60	1
71610-930-54	Pregabalin	84 in 1 BOTTLE	CAPSULE	84	1
71610-930-60	Pregabalin	90 in 1 BOTTLE	CAPSULE	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-930-30	EA - Each	71610-930	4c3c0603-1eba-4b68-91c5-61001fb05245	1	2025-09-12
71610-930-46	EA - Each	71610-930	64865579-7f6f-4af0-9c5f-f6248bb58e7c	1	2025-09-12
71610-930-53	EA - Each	71610-930	d422bf88-8ed8-4afe-8cbd-01d65c2923e2	1	2025-09-12
71610-930-54	EA - Each	71610-930	a07f75f9-1a5f-4458-bd99-c4e7410346f8	1	2025-09-12
71610-930-60	EA - Each	71610-930	cfd84f8b-836b-474f-8f8a-7bdb42c91978	1	2025-09-12

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 4 of 5 · 87 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	d2804923-a466-6dc6-e053-2a95a90a4182	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	f5d9b625-783c-bd78-e053-2995a90a37d2	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	f8ae62be-3a68-be6b-e053-6394a90ab627	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Quality Care Products, LLC	59432752-c8d8-4396-95dd-0e04c55bc82b	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Quality Care Products, LLC	1e087436-0534-4de2-b310-a5cc0e46adbd	2024-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Advanced Rx Pharmacy of Tennessee, LLC	f98c5df7-9b85-eacc-e053-6294a90a88ec	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	aa55a53c-96f6-4e0a-8b1d-e9d36e6ef2ec	2024-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	29a869b8-0d9f-4e3f-820a-061aa42ee482	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	d70a5102-eb8d-45f1-acd0-692e9208428e	2024-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	59f94cd9-0fc9-4e55-8004-578971a1b42f	2024-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Advanced Rx of Tennessee, LLC	1a15cd11-0db9-2bc8-e063-6394a90a11fb	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	15ea709a-d502-41ea-e063-6394a90ad97d	2024-04-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	124d7552-e48d-b160-e063-6294a90a196f	2024-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	11fe25cd-1aca-0e63-e063-6394a90a197e	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Proficient Rx LP	38e80423-0194-4064-9447-abfd29fce1da	2023-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	27d02970-5f8b-4f4f-b89e-e42cc78ddaa3	2023-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Proficient Rx LP	137ffe30-ff8b-409d-a719-6be19d4d9522	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Proficient Rx LP	1d76c6a3-7899-4dec-afcc-2b575dfa6c25	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Proficient Rx LP	920c57e0-ddfe-4750-b353-5f96b65443cf	2023-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	df80e09f-3d57-47a0-ba58-bb79e9ba1953	2022-11-29	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
483448	pregabalin 50 MG Oral Capsule	PSN	3ab4efb3-1ae5-2504-e063-6294a90a6d1d	1
483448	pregabalin 50 MG Oral Capsule	SCD	3ab4efb3-1ae5-2504-e063-6294a90a6d1d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71610-930-30	71610093030	30 CAPSULE in 1 BOTTLE (71610-930-30)	30 capsule	2025-07-24	No	No	Current
71610-930-46	71610093046	56 CAPSULE in 1 BOTTLE (71610-930-46)	56 capsule	2025-07-24	No	No	Current
71610-930-53	71610093053	60 CAPSULE in 1 BOTTLE (71610-930-53)	60 capsule	2025-07-24	No	No	Current
71610-930-54	71610093054	84 CAPSULE in 1 BOTTLE (71610-930-54)	84 capsule	2025-07-24	No	No	Current
71610-930-60	71610093060	90 CAPSULE in 1 BOTTLE (71610-930-60)	90 capsule	2025-07-24	No	No	Current