Pregabalin

Product NDC: 71610-999
Requested package NDC: 71610-999-75
11-digit product format: 716100999
Labeler code: 71610
Product ID: 71610-999_51163e0c-e671-3dc4-e063-6294a90abde9
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: 2025-12-10
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 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
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 8 · 320 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	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…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208677-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208677-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208677-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208677-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208677-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208677-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208677-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208677-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208677-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208677-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208677-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208677-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208677-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208677-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208677-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208677-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 320 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	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…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208677-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208677-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208677-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208677-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208677-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208677-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208677-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208677-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208677-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208677-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208677-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208677-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208677-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208677-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208677-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208677-008	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	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
4ddf9ede-5e8b-b5e1-e063-6394a90ac7f3	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
71610-999-30	Pregabalin	30 in 1 BOTTLE	CAPSULE	30	4
71610-999-46	Pregabalin	56 in 1 BOTTLE	CAPSULE	56	4
71610-999-53	Pregabalin	60 in 1 BOTTLE	CAPSULE	60	4
71610-999-70	Pregabalin	120 in 1 BOTTLE	CAPSULE	120	4
71610-999-75	Pregabalin	150 in 1 BOTTLE	CAPSULE	150	4
71610-999-80	Pregabalin	180 in 1 BOTTLE	CAPSULE	180	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-999-30	EA - Each	71610-999	dc52fb34-322a-4dbd-9005-ef80cd26923f	1	2026-05-22
71610-999-46	EA - Each	71610-999	9b2b21ca-5350-4955-91a3-853a9d2433c2	1	2026-05-22
71610-999-53	EA - Each	71610-999	5a5fcf53-84bf-4123-8ad3-2426b7618aca	1	2026-05-22
71610-999-70	EA - Each	71610-999	c50faaec-42ad-4749-a456-06631143c283	1	2026-05-22

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 5 · 87 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	St. Mary's Medical Park Pharmacy	fc5dd378-950f-949b-e053-6394a90a3ca2	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	St. Mary's Medical Park Pharmacy	9235cd08-7a25-4b81-e053-2995a90a539c	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	ST. MARY'S MEDICAL PARK PHARMACY	923743f0-f557-9143-e053-2a95a90a21ae	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	St. Mary's Medical Park Pharmacy	923745e9-17a2-a5f7-e053-2a95a90aed38	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	45abbcb4-6a38-469d-9671-24b2c25e5b18	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	4ddf9ede-5e8b-b5e1-e063-6394a90ac7f3	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677 ndc (package): 71610-999-75 ndc (product): 71610-999 ndc11 (package): 71610099975
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	4d53c8e2-f03f-0f5b-e063-6294a90a23c6	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	4ef59b1c-1273-5e54-e063-6294a90a0ec9	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	1a8d8292-1f94-46da-bade-8c4054201343	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	b977269a-7d62-44a2-bd0d-11c54b872836	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	fd01590e-5b90-4a77-ad5f-76adabf3c32e	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	4d63908b-96be-554c-e063-6394a90af510	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	8a7acea4-108d-40d2-a2a7-36088be97248	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	025c3adb-5f6b-45f5-a4c6-cea8e57102e3	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	2ceccc4d-97e2-4eb0-841f-23609187710c	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	247aedca-ae27-44c6-b32c-c95d26454566	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	e1ed81bc-1597-4bc5-80cd-09977a154e4b	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	fd568ede-dac7-4910-bb18-65fb00f2636e	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Proficient Rx LP	32789571-a566-46fa-ba41-bd3c86276ecf	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208677 application number: ANDA208677
Pregabalin	PREGABALIN	Bryant Ranch Prepack	c60f6b1e-7a24-41b2-8435-e20583a732c6	2026-03-30	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
483450	pregabalin 75 MG Oral Capsule	PSN	4ddf9ede-5e8b-b5e1-e063-6394a90ac7f3	4
483450	pregabalin 75 MG Oral Capsule	SCD	4ddf9ede-5e8b-b5e1-e063-6394a90ac7f3	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71610-999-75	71610099975	150 CAPSULE in 1 BOTTLE (71610-999-75)	150 capsule	2026-04-21	No	No	Current