FDA.reportPublic FDA data

Lyrica

Product NDC
63539-013
Requested package NDC
63539-013-41
11-digit product format
635390013
Labeler code
63539
Product ID
63539-013_bfdec19d-6a54-449c-95b4-908d28e5369a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
U.S. Pharmaceuticals
Application
NDA021446
Marketing category
NDA
Marketing start
2004-12-30
Marketing end
0000-00-00
Substance
PREGABALIN
Active strength
50 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63539-01363539-013-41DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021446-001LYRICAPREGABALIN25MGCAPSULE / ORALABRLD2004-12-30
N021446-002LYRICAPREGABALIN50MGCAPSULE / ORALABRLD2004-12-30
N021446-003LYRICAPREGABALIN75MGCAPSULE / ORALABRLD2004-12-30
N021446-004LYRICAPREGABALIN100MGCAPSULE / ORALABRLD2004-12-30
N021446-005LYRICAPREGABALIN150MGCAPSULE / ORALABRLD2004-12-30
N021446-006LYRICAPREGABALIN200MGCAPSULE / ORALABRLD2004-12-30
N021446-007LYRICAPREGABALIN225MGCAPSULE / ORALABRLD2004-12-30
N021446-008LYRICAPREGABALIN300MGCAPSULE / ORALABRLD, RS2004-12-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-productTE code
N021446-001AB
N021446-002AB
N021446-003AB
N021446-004AB
N021446-005AB
N021446-006AB
N021446-007AB
N021446-008AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021446-001LYRICA25MGCAPSULE / ORALABRLD2004-12-30a50c72e98297…
2026-08-01 22:54:322026-06N021446-002LYRICA50MGCAPSULE / ORALABRLD2004-12-30a50c72e98297…
2026-08-01 22:54:322026-06N021446-003LYRICA75MGCAPSULE / ORALABRLD2004-12-30a50c72e98297…
2026-08-01 22:54:322026-06N021446-004LYRICA100MGCAPSULE / ORALABRLD2004-12-30a50c72e98297…
2026-08-01 22:54:322026-06N021446-005LYRICA150MGCAPSULE / ORALABRLD2004-12-30a50c72e98297…
2026-08-01 22:54:322026-06N021446-006LYRICA200MGCAPSULE / ORALABRLD2004-12-30a50c72e98297…
2026-08-01 22:54:322026-06N021446-007LYRICA225MGCAPSULE / ORALABRLD2004-12-30a50c72e98297…
2026-08-01 22:54:322026-06N021446-008LYRICA300MGCAPSULE / ORALABRLD, RS2004-12-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021446-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N021446-002AB1a50c72e98297…
2026-08-01 22:54:322026-06N021446-003AB1a50c72e98297…
2026-08-01 22:54:322026-06N021446-004AB1a50c72e98297…
2026-08-01 22:54:322026-06N021446-005AB1a50c72e98297…
2026-08-01 22:54:322026-06N021446-006AB1a50c72e98297…
2026-08-01 22:54:322026-06N021446-007AB1a50c72e98297…
2026-08-01 22:54:322026-06N021446-008AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LyricaPREGABALINViatris Specialty LLCd4734e7d-5079-455e-8ff5-8f4539c998a92025-04-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 021446
application number: NDA021446
LyricaPREGABALINParke-Davis Div of Pfizer Inc60185c88-ecfd-46f9-adb9-b97c6b00a5532020-06-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 021446
application number: NDA021446

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63539-013-412021-08-14C16284748780-1c7ccaba7-2475-fd44-e053-dadaa90aa01bThese 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
63539-013-412021-07-23C16284748780-1c7ccaba7-2475-fd44-e053-dadaa90aa01bThese 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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREGABALINACTIVE INGREDIENT55JG375S6MLYRICA (PREGABALIN) CAPSULE [U.S. PHARMACEUTICALS]2
PREGABALINACTIVE MOIETY55JG375S6MLYRICA (PREGABALIN) CAPSULE [U.S. PHARMACEUTICALS]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LYRICA (PREGABALIN) CAPSULE [U.S. PHARMACEUTICALS]2
GELATININACTIVE INGREDIENT2G86QN327LLYRICA (PREGABALIN) CAPSULE [U.S. PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLYRICA (PREGABALIN) CAPSULE [U.S. PHARMACEUTICALS]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLYRICA (PREGABALIN) CAPSULE [U.S. PHARMACEUTICALS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LYRICA (PREGABALIN) CAPSULE [U.S. PHARMACEUTICALS]2
SHELLACINACTIVE INGREDIENT46N107B71OLYRICA (PREGABALIN) CAPSULE [U.S. PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LYRICA (PREGABALIN) CAPSULE [U.S. PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLYRICA (PREGABALIN) CAPSULE [U.S. PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLYRICA (PREGABALIN) CAPSULE [U.S. PHARMACEUTICALS]2
TALCINACTIVE INGREDIENT7SEV7J4R1ULYRICA (PREGABALIN) CAPSULE [U.S. PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLYRICA (PREGABALIN) CAPSULE [U.S. PHARMACEUTICALS]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63539-013-41635390013411 BLISTER PACK in 1 CARTON (63539-013-41) > 21 CAPSULE in 1 BLISTER PACK1 blister pack2004-12-300000-00-00NoNoCurrent