FDA.reportPublic FDA data

Lyrica CR

Product NDC
58151-245
11-digit product format
581510245
Labeler code
58151
Product ID
58151-245_67715d17-5ade-44ba-a5db-ba20d30d6da1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA209501
Marketing category
NDA
Marketing start
2024-11-26
Substance
PREGABALIN
Active strength
82.5 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209501-001LYRICA CRPREGABALIN82.5MGTABLET, EXTENDED RELEASE / ORALABRLD2017-10-11
N209501-002LYRICA CRPREGABALIN165MGTABLET, EXTENDED RELEASE / ORALABRLD2017-10-11
N209501-003LYRICA CRPREGABALIN330MGTABLET, EXTENDED RELEASE / ORALABRLD, RS2017-10-11

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
N209501-001AB
N209501-002AB
N209501-003AB

Orange Book patents#

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209501-001100224472026-11-02U-21362018-08-16
N209501-001100224472026-11-02U-21372018-08-16
N209501-00189456202026-11-02U-2136Drug product2017-11-09
N209501-00189456202026-11-02U-2137Drug product2017-11-09
N209501-00191445592026-11-02Drug product2017-11-09
N209501-00110022447*PED2027-05-02Pediatric extension
N209501-0018945620*PED2027-05-02Pediatric extension
N209501-0019144559*PED2027-05-02Pediatric extension
N209501-002100224472026-11-02U-21372018-08-16
N209501-002100224472026-11-02U-21362018-08-16
N209501-00289456202026-11-02U-2137Drug product2017-11-09
N209501-00289456202026-11-02U-2136Drug product2017-11-09
N209501-00291445592026-11-02Drug product2017-11-09
N209501-00210022447*PED2027-05-02Pediatric extension
N209501-0028945620*PED2027-05-02Pediatric extension
N209501-0029144559*PED2027-05-02Pediatric extension
N209501-003100224472026-11-02U-21372018-08-16
N209501-003100224472026-11-02U-21362018-08-16
N209501-00389456202026-11-02U-2137Drug product2017-11-09
N209501-00389456202026-11-02U-2136Drug product2017-11-09
N209501-00391445592026-11-02Drug product2017-11-09
N209501-00310022447*PED2027-05-02Pediatric extension
N209501-0038945620*PED2027-05-02Pediatric extension
N209501-0039144559*PED2027-05-02Pediatric extension

Additional Listing Data#

Finished product
Yes
Brand name base
Lyrica CR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN82.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui1988974, 1988977, 1988980, 1994389, 1994392, 1994395

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58151-245-93Lyrica CR30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-245-93EA - Each58151-2458db1db63-2c82-4f46-9404-67c8c13f58e912024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-245LYRICA CR (PREGABALIN) TABLET, FILM COATED, EXTENDED RELEASE [VIATRIS SPECIALTY LLC]5Current NDC, 1 package rows20250508_f280bbd8-2af2-444a-bd96-e409337ca6dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1994389Lyrica CR 165 MG 24HR Extended Release Oral TabletPSNf280bbd8-2af2-444a-bd96-e409337ca6dd7
1994392Lyrica CR 330 MG 24HR Extended Release Oral TabletPSNf280bbd8-2af2-444a-bd96-e409337ca6dd7
1994395Lyrica CR 82.5 MG 24HR Extended Release Oral TabletPSNf280bbd8-2af2-444a-bd96-e409337ca6dd7
1988974pregabalin 165 MG 24HR Extended Release Oral TabletPSNf280bbd8-2af2-444a-bd96-e409337ca6dd7
1988977pregabalin 330 MG 24HR Extended Release Oral TabletPSNf280bbd8-2af2-444a-bd96-e409337ca6dd7
1988980pregabalin 82.5 MG 24HR Extended Release Oral TabletPSNf280bbd8-2af2-444a-bd96-e409337ca6dd7
199438924 HR pregabalin 165 MG Extended Release Oral Tablet [Lyrica]SBDf280bbd8-2af2-444a-bd96-e409337ca6dd7
199439224 HR pregabalin 330 MG Extended Release Oral Tablet [Lyrica]SBDf280bbd8-2af2-444a-bd96-e409337ca6dd7
199439524 HR pregabalin 82.5 MG Extended Release Oral Tablet [Lyrica]SBDf280bbd8-2af2-444a-bd96-e409337ca6dd7
198897424 HR pregabalin 165 MG Extended Release Oral TabletSCDf280bbd8-2af2-444a-bd96-e409337ca6dd7
198897724 HR pregabalin 330 MG Extended Release Oral TabletSCDf280bbd8-2af2-444a-bd96-e409337ca6dd7
198898024 HR pregabalin 82.5 MG Extended Release Oral TabletSCDf280bbd8-2af2-444a-bd96-e409337ca6dd7
199438924 HR Lyrica 165 MG Extended Release Oral TabletSYf280bbd8-2af2-444a-bd96-e409337ca6dd7
199439224 HR Lyrica 330 MG Extended Release Oral TabletSYf280bbd8-2af2-444a-bd96-e409337ca6dd7
199439524 HR Lyrica 82.5 MG Extended Release Oral TabletSYf280bbd8-2af2-444a-bd96-e409337ca6dd7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
58151-245-935815102459330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-245-93) 2024-11-26NoNoCurrent