Lyrica

Product NDC: 21695-278
11-digit product format: 216950278
Labeler code: 21695
Product ID: 21695-278_8fb45a78-b2d8-45dd-b844-0de21d1fdde9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREGABALIN
Dosage form: CAPSULE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA021724
Marketing category: NDA
Marketing start: 2005-06-10
Marketing end: 0000-00-00
Substance: PREGABALIN
Active strength: 75 mg/1
DEA schedule: CV
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-278		I	Inactivated by FDA	2026-10-02
excluded package	package	21695-278	21695-278-30	I	Inactivated by FDA	2026-10-02
excluded package	package	21695-278	21695-278-60	I	Inactivated by FDA	2026-10-02
excluded package	package	21695-278	21695-278-72	I	Inactivated by FDA	2026-10-02
excluded package	package	21695-278	21695-278-90	I	Inactivated by FDA	2026-10-02

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 110 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-278-72	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-278-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-278-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-278-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-278-72	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-278-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-278-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-278-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-278-72	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-278-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-278-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-278-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-278-72	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-278-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-278-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-278-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-278-72	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-278-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-278-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-278-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-278-72	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-278-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-278-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-278-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-278-72	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-278-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-278-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-278-90	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-278-72	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-278-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-278-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-278-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-278-72	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-278-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-278-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-278-90	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-278-72	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-278-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-278-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-278-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-278-72	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-278-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-278-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-278-90	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-278-72	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-278-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-278-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-278-90	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Related label table
NDC	Related label
21695-278-30	These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004
21695-278-60	These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004
21695-278-72	These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004
21695-278-90	These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-278-30	Lyrica	30 in 1 BOTTLE	CAPSULE	30	1
21695-278-60	Lyrica	60 in 1 BOTTLE	CAPSULE	60	1
21695-278-72	Lyrica	120 in 1 BOTTLE	CAPSULE	120	1
21695-278-90	Lyrica	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
21695-278-30	EA - Each	21695-278	7d1d8856-3ac0-40fe-a616-cc1f19d46155	1	2012-07-24
21695-278-60	EA - Each	21695-278	bebadd68-363f-493c-bb14-42c3c02e42c4	1	2012-07-24
21695-278-72	EA - Each	21695-278	0cd88829-ee2e-4041-bad8-af2e2adfe6e4	1	2012-07-24
21695-278-90	EA - Each	21695-278	b4eb9c10-61d1-464b-b70e-6c3a74c5a8f2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PREGABALIN	ACTIVE INGREDIENT	55JG375S6M	LYRICA (PREGABALIN) CAPSULE [REBEL DISTRIBUTORS CORP]	1
PREGABALIN	ACTIVE MOIETY	55JG375S6M	LYRICA (PREGABALIN) CAPSULE [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LYRICA (PREGABALIN) CAPSULE [REBEL DISTRIBUTORS CORP]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LYRICA (PREGABALIN) CAPSULE [REBEL DISTRIBUTORS CORP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LYRICA (PREGABALIN) CAPSULE [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LYRICA (PREGABALIN) CAPSULE [REBEL DISTRIBUTORS CORP]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	LYRICA (PREGABALIN) CAPSULE [REBEL DISTRIBUTORS CORP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LYRICA (PREGABALIN) CAPSULE [REBEL DISTRIBUTORS CORP]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LYRICA (PREGABALIN) CAPSULE [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LYRICA (PREGABALIN) CAPSULE [REBEL DISTRIBUTORS CORP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LYRICA (PREGABALIN) CAPSULE [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LYRICA (PREGABALIN) CAPSULE [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LYRICA (PREGABALIN) CAPSULE [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LYRICA (PREGABALIN) CAPSULE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-278	LYRICA (PREGABALIN) CAPSULE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 4 package rows	20110622_8fb45a78-b2d8-45dd-b844-0de21d1fdde9.zip

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
607018	Lyrica 100 MG Oral Capsule	PSN	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
607020	Lyrica 150 MG Oral Capsule	PSN	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
607022	Lyrica 200 MG Oral Capsule	PSN	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
607026	Lyrica 25 MG Oral Capsule	PSN	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
607028	Lyrica 300 MG Oral Capsule	PSN	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
607033	Lyrica 50 MG Oral Capsule	PSN	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
607038	Lyrica 75 MG Oral Capsule	PSN	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
483438	pregabalin 100 MG Oral Capsule	PSN	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
483440	pregabalin 150 MG Oral Capsule	PSN	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
483446	pregabalin 200 MG Oral Capsule	PSN	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
483442	pregabalin 25 MG Oral Capsule	PSN	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
483444	pregabalin 300 MG Oral Capsule	PSN	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
483448	pregabalin 50 MG Oral Capsule	PSN	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
483450	pregabalin 75 MG Oral Capsule	PSN	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
607018	pregabalin 100 MG Oral Capsule [Lyrica]	SBD	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
607020	pregabalin 150 MG Oral Capsule [Lyrica]	SBD	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
607022	pregabalin 200 MG Oral Capsule [Lyrica]	SBD	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
607026	pregabalin 25 MG Oral Capsule [Lyrica]	SBD	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
607028	pregabalin 300 MG Oral Capsule [Lyrica]	SBD	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
607033	pregabalin 50 MG Oral Capsule [Lyrica]	SBD	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
607038	pregabalin 75 MG Oral Capsule [Lyrica]	SBD	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
483438	pregabalin 100 MG Oral Capsule	SCD	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
483440	pregabalin 150 MG Oral Capsule	SCD	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
483446	pregabalin 200 MG Oral Capsule	SCD	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
483442	pregabalin 25 MG Oral Capsule	SCD	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
483444	pregabalin 300 MG Oral Capsule	SCD	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
483448	pregabalin 50 MG Oral Capsule	SCD	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
483450	pregabalin 75 MG Oral Capsule	SCD	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
607018	Lyrica 100 MG Oral Capsule	SY	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
607020	Lyrica 150 MG Oral Capsule	SY	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
607022	Lyrica 200 MG Oral Capsule	SY	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
607026	Lyrica 25 MG Oral Capsule	SY	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
607028	Lyrica 300 MG Oral Capsule	SY	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
607033	Lyrica 50 MG Oral Capsule	SY	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1
607038	Lyrica 75 MG Oral Capsule	SY	8fb45a78-b2d8-45dd-b844-0de21d1fdde9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-278-30	21695027830	30 in 1 BOTTLE	Historical
21695-278-60	21695027860	60 in 1 BOTTLE	Historical
21695-278-72	21695027872	120 in 1 BOTTLE	Historical
21695-278-90	21695027890	90 in 1 BOTTLE	Historical