FDA.reportPublic FDA data

Lyrica

Product NDC
49999-905
Requested package NDC
49999-905-30
11-digit product format
499990905
Labeler code
49999
Product ID
49999-905_58ec6ff7-6cca-4ad1-99b5-e32f812f14be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
NDA021724
Marketing category
NDA
Marketing start
2012-02-06
Marketing end
2021-10-31
Substance
PREGABALIN
Active strength
100 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49999-90549999-905-30DDiscontinued by firm2026-08-03

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 1 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49999-90549999-905-30DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49999-90549999-905-30DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49999-90549999-905-30DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49999-90549999-905-30DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49999-90549999-905-30DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49999-90549999-905-30DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49999-90549999-905-30DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49999-90549999-905-30DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49999-90549999-905-30DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49999-90549999-905-30DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49999-90549999-905-30DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49999-90549999-905-30DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49999-905-30EA - Each49999-905abd521c3-22b4-4ae2-bdfc-7b6782bae26612012-07-24
49999-905-60EA - Each49999-905fe1b1f69-9213-4f72-8448-528b35b28adb12012-07-24
49999-905-90EA - Each49999-90546c8d937-f03a-479b-b6e8-caa58956318c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREGABALINACTIVE INGREDIENT55JG375S6MLYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3544
PREGABALINACTIVE MOIETY55JG375S6MLYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3544
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3544
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3544
GELATININACTIVE INGREDIENT2G86QN327LLYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3544
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3544
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3544
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3544
SHELLACINACTIVE INGREDIENT46N107B71OLYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3544
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3544
TALCINACTIVE INGREDIENT7SEV7J4R1ULYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3544
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLYRICA (PREGABALIN) CAPSULE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3544

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49999-905-304999909053030 CAPSULE in 1 BOTTLE (49999-905-30) 30 capsule2012-02-062021-10-31NoNoCurrent