Pregabalin

Product NDC: 69097-954
11-digit product format: 690970954
Labeler code: 69097
Product ID: 69097-954_96d9d734-42e6-474d-a75e-0381de0a8ec1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREGABALIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Cipla USA, Inc.
Application: ANDA211384
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: 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
A211384-001	PREGABALIN	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19
A211384-002	PREGABALIN	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19
A211384-003	PREGABALIN	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19
A211384-004	PREGABALIN	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19
A211384-005	PREGABALIN	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19
A211384-006	PREGABALIN	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19
A211384-007	PREGABALIN	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19
A211384-008	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
A211384-001	AB
A211384-002	AB
A211384-003	AB
A211384-004	AB
A211384-005	AB
A211384-006	AB
A211384-007	AB
A211384-008	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	A211384-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211384-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211384-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-008	PREGABALIN	300MG	CAPSULE / ORAL	AB	2019-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211384-001	PREGABALIN	25MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-002	PREGABALIN	50MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-003	PREGABALIN	75MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-004	PREGABALIN	100MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-005	PREGABALIN	150MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-006	PREGABALIN	200MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-007	PREGABALIN	225MG	CAPSULE / ORAL	AB	2019-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-008	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	A211384-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-006	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-007	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211384-008	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211384-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211384-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211384-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211384-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211384-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211384-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211384-008	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	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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
483438	Internal RxNorm lookup
483440	Internal RxNorm lookup
483442	Internal RxNorm lookup
483444	Internal RxNorm lookup
483446	Internal RxNorm lookup
483448	Internal RxNorm lookup
483450	Internal RxNorm lookup
577127	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
17a8087c-579f-42de-ae92-006ea64def2a	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
69097-954-05	Pregabalin	90 in 1 BOTTLE	CAPSULE	90		5
69097-954-12	Pregabalin	500 in 1 BOTTLE	CAPSULE	500		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69097-954-05	EA - Each	69097-954	bbd33274-b99c-4103-87d6-b21f9cb67be5	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-954	PREGABALIN CAPSULE [CIPLA USA, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20230119_17a8087c-579f-42de-ae92-006ea64def2a.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	bf710bcf-75ed-4184-b9c3-81cd05a780a4	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211384 application number: ANDA211384
Pregabalin	PREGABALIN	Aphena Pharma Solutions - Tennessee, LLC	ef7c2e2c-c314-4bfd-a9fa-39f0b0884d34	2025-07-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211384 application number: ANDA211384
Pregabalin	PREGABALIN	Cipla USA, Inc.	17a8087c-579f-42de-ae92-006ea64def2a	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211384 application number: ANDA211384 ndc (product): 69097-954
Pregabalin	PREGABALIN	Exelan Pharmaceuticals Inc.	3fdc6e94-2504-416c-81dd-2db9bc194ebb	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211384 application number: ANDA211384

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
483438	pregabalin 100 MG Oral Capsule	PSN	17a8087c-579f-42de-ae92-006ea64def2a	5
483440	pregabalin 150 MG Oral Capsule	PSN	17a8087c-579f-42de-ae92-006ea64def2a	5
483446	pregabalin 200 MG Oral Capsule	PSN	17a8087c-579f-42de-ae92-006ea64def2a	5
577127	pregabalin 225 MG Oral Capsule	PSN	17a8087c-579f-42de-ae92-006ea64def2a	5
483442	pregabalin 25 MG Oral Capsule	PSN	17a8087c-579f-42de-ae92-006ea64def2a	5
483444	pregabalin 300 MG Oral Capsule	PSN	17a8087c-579f-42de-ae92-006ea64def2a	5
483448	pregabalin 50 MG Oral Capsule	PSN	17a8087c-579f-42de-ae92-006ea64def2a	5
483450	pregabalin 75 MG Oral Capsule	PSN	17a8087c-579f-42de-ae92-006ea64def2a	5
483438	pregabalin 100 MG Oral Capsule	SCD	17a8087c-579f-42de-ae92-006ea64def2a	5
483440	pregabalin 150 MG Oral Capsule	SCD	17a8087c-579f-42de-ae92-006ea64def2a	5
483446	pregabalin 200 MG Oral Capsule	SCD	17a8087c-579f-42de-ae92-006ea64def2a	5
577127	pregabalin 225 MG Oral Capsule	SCD	17a8087c-579f-42de-ae92-006ea64def2a	5
483442	pregabalin 25 MG Oral Capsule	SCD	17a8087c-579f-42de-ae92-006ea64def2a	5
483444	pregabalin 300 MG Oral Capsule	SCD	17a8087c-579f-42de-ae92-006ea64def2a	5
483448	pregabalin 50 MG Oral Capsule	SCD	17a8087c-579f-42de-ae92-006ea64def2a	5
483450	pregabalin 75 MG Oral Capsule	SCD	17a8087c-579f-42de-ae92-006ea64def2a	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69097-954-05	69097095405	90 CAPSULE in 1 BOTTLE (69097-954-05)	90 capsule	2019-07-19	0000-00-00	No	No	Current
69097-954-12	69097095412	500 CAPSULE in 1 BOTTLE (69097-954-12)	500 capsule	2019-07-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pregabalin	Cipla USA, Inc. \| InvaGen Pharmaceuticals, Inc \| Ascent Pharmaceuticals, Inc	2025-05-01	HUMAN PRESCRIPTION DRUG LABEL	5