Lyrica

Product NDC: 52959-897
11-digit product format: 529590897
Labeler code: 52959
Product ID: 52959-897_4c9b2c15-78b0-42b1-a146-026282c33076
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PREGABALIN
Dosage form: CAPSULE
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: NDA021724
Marketing category: NDA
Marketing start: 2004-12-30
Marketing end: 0000-00-00
Substance: PREGABALIN
Active strength: 150 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-897		I	Inactivated by FDA	2026-10-02
excluded package	package	52959-897	52959-897-30	I	Inactivated by FDA	2026-10-02
excluded package	package	52959-897	52959-897-60	I	Inactivated by FDA	2026-10-02
excluded package	package	52959-897	52959-897-90	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 · 88 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	52959-897-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-897-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-897-90	`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	52959-897-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-897-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-897-90	`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	52959-897-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-897-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-897-90	`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	52959-897-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-897-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-897-90	`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	52959-897-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-897-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-897-90	`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	52959-897-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-897-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-897-90	`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	52959-897-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-897-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-897-90	`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	52959-897-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-897-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-897-90	`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	52959-897-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-897-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-897-90	`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	52959-897-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-897-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-897-90	`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	52959-897-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-897-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-897-90	`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	52959-897-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-897-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-897-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52959-897-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52959-897-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52959-897-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52959-897-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52959-897-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52959-897-90	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52959-897-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52959-897-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52959-897-90	`1332a3947898…`	`d4bfe170f9cd…`

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52959-897-30	2019-11-13	C162847	48780-1	97449f38-bd20-f6ea-e053-dbdaa90aa703	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
52959-897-60	2019-11-13	C162847	48780-1	97449f38-bd20-f6ea-e053-dbdaa90aa703	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
52959-897-90	2019-11-13	C162847	48780-1	97449f38-bd20-f6ea-e053-dbdaa90aa703	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
52959-897-30	Lyrica	30 in 1 BLISTER PACK	CAPSULE	30	4
52959-897-60	Lyrica	60 in 1 BOTTLE	CAPSULE	60	4
52959-897-90	Lyrica	90 in 1 BOTTLE	CAPSULE	90	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-897-30	EA - Each	52959-897	69ff4d31-1188-46de-a487-331e5cdf2141	1	2012-07-24
52959-897-60	EA - Each	52959-897	e0d34c1e-9f28-4b3c-ac3f-cbf019bd6fdc	1	2012-07-24
52959-897-90	EA - Each	52959-897	52e386e0-ae24-4856-a77f-5aeef128ecc7	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 [H.J. HARKINS COMPANY, INC.]	4
PREGABALIN	ACTIVE MOIETY	55JG375S6M	LYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	LYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	LYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]	4
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	LYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	LYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	LYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	LYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-897	LYRICA (PREGABALIN) CAPSULE [H.J. HARKINS COMPANY, INC.]	4	Legacy NDC, 3 package rows	20111019_a262d7c6-2aa9-433c-b801-d8b2dcd68a0f.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	a262d7c6-2aa9-433c-b801-d8b2dcd68a0f	4
607020	Lyrica 150 MG Oral Capsule	PSN	a262d7c6-2aa9-433c-b801-d8b2dcd68a0f	4
607033	Lyrica 50 MG Oral Capsule	PSN	a262d7c6-2aa9-433c-b801-d8b2dcd68a0f	4
607038	Lyrica 75 MG Oral Capsule	PSN	a262d7c6-2aa9-433c-b801-d8b2dcd68a0f	4
483438	pregabalin 100 MG Oral Capsule	PSN	a262d7c6-2aa9-433c-b801-d8b2dcd68a0f	4
483440	pregabalin 150 MG Oral Capsule	PSN	a262d7c6-2aa9-433c-b801-d8b2dcd68a0f	4
483448	pregabalin 50 MG Oral Capsule	PSN	a262d7c6-2aa9-433c-b801-d8b2dcd68a0f	4
483450	pregabalin 75 MG Oral Capsule	PSN	a262d7c6-2aa9-433c-b801-d8b2dcd68a0f	4
607018	pregabalin 100 MG Oral Capsule [Lyrica]	SBD	a262d7c6-2aa9-433c-b801-d8b2dcd68a0f	4
607020	pregabalin 150 MG Oral Capsule [Lyrica]	SBD	a262d7c6-2aa9-433c-b801-d8b2dcd68a0f	4
607033	pregabalin 50 MG Oral Capsule [Lyrica]	SBD	a262d7c6-2aa9-433c-b801-d8b2dcd68a0f	4
607038	pregabalin 75 MG Oral Capsule [Lyrica]	SBD	a262d7c6-2aa9-433c-b801-d8b2dcd68a0f	4
483438	pregabalin 100 MG Oral Capsule	SCD	a262d7c6-2aa9-433c-b801-d8b2dcd68a0f	4
483440	pregabalin 150 MG Oral Capsule	SCD	a262d7c6-2aa9-433c-b801-d8b2dcd68a0f	4
483448	pregabalin 50 MG Oral Capsule	SCD	a262d7c6-2aa9-433c-b801-d8b2dcd68a0f	4
483450	pregabalin 75 MG Oral Capsule	SCD	a262d7c6-2aa9-433c-b801-d8b2dcd68a0f	4
607018	Lyrica 100 MG Oral Capsule	SY	a262d7c6-2aa9-433c-b801-d8b2dcd68a0f	4
607020	Lyrica 150 MG Oral Capsule	SY	a262d7c6-2aa9-433c-b801-d8b2dcd68a0f	4
607033	Lyrica 50 MG Oral Capsule	SY	a262d7c6-2aa9-433c-b801-d8b2dcd68a0f	4
607038	Lyrica 75 MG Oral Capsule	SY	a262d7c6-2aa9-433c-b801-d8b2dcd68a0f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-897-30	52959089730	30 in 1 BLISTER PACK	Historical
52959-897-60	52959089760	60 in 1 BOTTLE	Historical
52959-897-90	52959089790	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lyrica	H.J. Harkins Company, Inc. \| Parke-Davis Div of Pfizer Inc \| Pfizer Pharmaceuticals LLC \| Pfizer Asia Pacific PTE Ltd \| Pfizer Manufacturing Deutschland GmbH \| Pfizer Ireland Pharmaceuticals \| Pfizer Ireland Pharmaceuticals (Ringaskiddy)	2011-10-17	HUMAN PRESCRIPTION DRUG LABEL	4