FDA.reportPublic FDA data

Pregabalin

Product NDC
68788-7520
11-digit product format
687887520
Labeler code
68788
Product ID
68788-7520_2d928f5a-9177-40e8-92bd-a57b4b1d0763
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA208677
Marketing category
ANDA
Marketing start
2019-07-19
Substance
PREGABALIN
Active strength
25 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pregabalin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483442

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-7520-12022-02-14C16284748780-1d6a99b39-aebe-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-32022-02-14C16284748780-1d6a99b39-aebe-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-62022-02-14C16284748780-1d6a99b39-aebe-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-92022-02-14C16284748780-1d6a99b39-aebe-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-12022-01-28C16284748780-1d6a99b39-aebe-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-32022-01-28C16284748780-1d6a99b39-aebe-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-62022-01-28C16284748780-1d6a99b39-aebe-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
68788-7520-92022-01-28C16284748780-1d6a99b39-aebe-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7520-1Pregabalin100 in 1 BOTTLECAPSULE1006
68788-7520-3Pregabalin30 in 1 BOTTLECAPSULE306
68788-7520-6Pregabalin60 in 1 BOTTLECAPSULE606
68788-7520-9Pregabalin90 in 1 BOTTLECAPSULE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7520-1EA - Each68788-7520e76b83cd-81e7-46f9-8bc2-941defaf86d912019-11-12
68788-7520-3EA - Each68788-7520c77e437b-f000-4937-9206-fd133b14d22912019-11-12
68788-7520-6EA - Each68788-752003db85e4-c61e-4472-86ca-f5bf23d2719e12019-11-12
68788-7520-9EA - Each68788-7520cd990bf0-bb1b-4749-8a1f-650b1f59905e12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7520PREGABALIN CAPSULE [PREFERRED PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 4 package rows20240802_ce1419bc-c348-4407-b320-e0598d5a7b19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483442pregabalin 25 MG Oral CapsulePSNce1419bc-c348-4407-b320-e0598d5a7b196
483442pregabalin 25 MG Oral CapsuleSCDce1419bc-c348-4407-b320-e0598d5a7b196

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7520-168788752001100 CAPSULE in 1 BOTTLE (68788-7520-1) 100 capsule2019-10-280000-00-00NoNoCurrent
68788-7520-36878875200330 CAPSULE in 1 BOTTLE (68788-7520-3) 30 capsule2019-10-280000-00-00NoNoCurrent
68788-7520-66878875200660 CAPSULE in 1 BOTTLE (68788-7520-6) 60 capsule2019-10-280000-00-00NoNoCurrent
68788-7520-96878875200990 CAPSULE in 1 BOTTLE (68788-7520-9) 90 capsule2019-10-280000-00-00NoNoCurrent