PREGABALIN

Product NDC: 72162-2304
Requested package NDC: 72162-2304-0
11-digit product format: 721622304
Labeler code: 72162
Product ID: 72162-2304_250c155b-3d38-41f9-945b-e983a206e583
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREGABALIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA210432
Marketing category: ANDA
Marketing start: 2019-07-19
Substance: PREGABALIN
Active strength: 150 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
A210432-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19
A210432-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19
A210432-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19
A210432-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19
A210432-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19
A210432-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19
A210432-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19
A210432-008	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
A210432-001	AB
A210432-002	AB
A210432-003	AB
A210432-004	AB
A210432-005	AB
A210432-006	AB
A210432-007	AB
A210432-008	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	A210432-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210432-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210432-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210432-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210432-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210432-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210432-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210432-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210432-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210432-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210432-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210432-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210432-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210432-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210432-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210432-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210432-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210432-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210432-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210432-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210432-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210432-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210432-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210432-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210432-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210432-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210432-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210432-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210432-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210432-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210432-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210432-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210432-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210432-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210432-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210432-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210432-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210432-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210432-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210432-008	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	A210432-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210432-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210432-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210432-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210432-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210432-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210432-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210432-008	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210432-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210432-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210432-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210432-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210432-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210432-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210432-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210432-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210432-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210432-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210432-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210432-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210432-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210432-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210432-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210432-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210432-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210432-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210432-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210432-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210432-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210432-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210432-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210432-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210432-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210432-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210432-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210432-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210432-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210432-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210432-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210432-008	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	150 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
483440	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
335e3bcb-10a3-481b-ad95-ee9ceaa3689e	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
72162-2304-0	PREGABALIN	1000 in 1 BOTTLE	CAPSULE	1000		101
72162-2304-9	PREGABALIN	90 in 1 BOTTLE	CAPSULE	90		101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-2304-0	EA - Each	72162-2304	51c9ad22-ee60-4b56-a18d-2544d2674b0b	1	2024-06-10
72162-2304-9	EA - Each	72162-2304	ab08d731-4219-411f-bf3a-e9847c2cf000	1	2024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-2304	PREGABALIN CAPSULE [BRYANT RANCH PREPACK]	100	Current NDC, 2 package rows	20240502_335e3bcb-10a3-481b-ad95-ee9ceaa3689e.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 1 of 1 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PREGABALIN	PREGABALIN	Cardinal Health 107, LLC	124176c7-d8ab-4bbe-b468-3e5d12f03e44	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210432 application number: ANDA210432
PREGABALIN	PREGABALIN	REMEDYREPACK INC.	1a8f13f6-0f4c-4194-ba37-b2d1a8fc4993	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210432 application number: ANDA210432
PREGABALIN	PREGABALIN	A-S Medication Solutions	54a9bfb4-dcff-491d-9676-1fe1d05e004c	2026-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210432 application number: ANDA210432
PREGABALIN	PREGABALIN	Major Pharmaceuticals	2420e2d7-c01a-4590-88c5-6fe5361747e9	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210432 application number: ANDA210432
PREGABALIN	PREGABALIN	Bryant Ranch Prepack	335e3bcb-10a3-481b-ad95-ee9ceaa3689e	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210432 application number: ANDA210432 ndc (package): 72162-2304-0 ndc (product): 72162-2304 ndc11 (package): 72162230400
PREGABALIN	PREGABALIN	Bryant Ranch Prepack	3ce4dfdf-e32f-40e8-9a13-e45d51539e08	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210432 application number: ANDA210432
PREGABALIN	PREGABALIN	Bryant Ranch Prepack	ca861bfb-caef-4764-bad5-c95a0d035475	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210432 application number: ANDA210432
PREGABALIN	PREGABALIN	Bryant Ranch Prepack	0101cd1f-4a95-40e9-86a8-ccde8d656e3d	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210432 application number: ANDA210432
PREGABALIN	PREGABALIN	Bryant Ranch Prepack	311e748a-7db4-4967-989b-5ed96871d99a	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210432 application number: ANDA210432
PREGABALIN	PREGABALIN	Bryant Ranch Prepack	ff55a40e-4a5a-40db-87b1-7ece1d5b316f	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210432 application number: ANDA210432
PREGABALIN	PREGABALIN	Bryant Ranch Prepack	72832f05-325e-4a72-8a33-da114e39c52d	2025-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210432 application number: ANDA210432
PREGABALIN	PREGABALIN	Rising Pharma Holdings, Inc.	dbebfa61-0685-41b4-8364-00b8d8b73714	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210432 application number: ANDA210432
Pregabalin	PREGABALIN	Advanced Rx of Tennessee, LLC	afc8d9f1-df31-607b-e053-2995a90a028c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210432 application number: ANDA210432
PREGABALIN	PREGABALIN	Quality Care Products, LLC	ff386af0-17d3-4f95-803b-b51cb79e5295	2024-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210432 application number: ANDA210432
Pregabalin	PREGABALIN	American Health Packaging	59da1a16-d409-49eb-9b44-397c77006043	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210432 application number: ANDA210432
PREGABALIN	PREGABALIN	Bryant Ranch Prepack	15b5e3d0-2bad-4363-99cb-e15819c41fda	2024-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210432 application number: ANDA210432
PREGABALIN	PREGABALIN	Asclemed USA, Inc.	69b8a843-a3a8-4d76-8418-f48288625030	2020-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210432 application number: ANDA210432
PREGABALIN	PREGABALIN	Proficient Rx LP	4624c58f-8f77-48fa-be0f-fca4010cc8ae	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210432 application number: ANDA210432
PREGABALIN	PREGABALIN	Proficient Rx LP	6022939f-92a8-4cb4-9f04-f237a4d73f6f	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210432 application number: ANDA210432

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
483440	pregabalin 150 MG Oral Capsule	PSN	335e3bcb-10a3-481b-ad95-ee9ceaa3689e	101
483440	pregabalin 150 MG Oral Capsule	SCD	335e3bcb-10a3-481b-ad95-ee9ceaa3689e	101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-2304-0	72162230400	1000 CAPSULE in 1 BOTTLE (72162-2304-0)	1000 capsule	2024-04-30	No	No	Current