FDA.reportPublic FDA data

Pregabalin

Product NDC
71610-315
11-digit product format
716100315
Labeler code
71610
Product ID
71610-315_d3a04565-4603-4165-b954-cc704e9f27b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA211384
Marketing category
ANDA
Marketing start
2019-07-19
Marketing end
0000-00-00
Substance
PREGABALIN
Active strength
75 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
71610-315-302024-03-04C16284748780-1f386c649-dcec-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-302024-03-04C16284748780-1f386c649-dcec-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-462024-03-04C16284748780-1f386c649-dcec-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-462024-03-04C16284748780-1f386c649-dcec-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-532024-03-04C16284748780-1f386c649-dcec-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-532024-03-04C16284748780-1f386c649-dcec-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-702024-03-04C16284748780-1f386c649-dcec-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-702024-03-04C16284748780-1f386c649-dcec-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-302023-01-30C16284748780-1f386c649-dcec-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-302023-01-30C16284748780-1f386c649-dcec-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-462023-01-30C16284748780-1f386c649-dcec-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-462023-01-30C16284748780-1f386c649-dcec-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-532023-01-30C16284748780-1f386c649-dcec-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-532023-01-30C16284748780-1f386c649-dcec-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-702023-01-30C16284748780-1f386c649-dcec-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004
71610-315-702023-01-30C16284748780-1f386c649-dcec-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. PREGABALIN capsules, for oral use, CV Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-315-30Pregabalin30 in 1 BOTTLECAPSULE3011
71610-315-46Pregabalin56 in 1 BOTTLECAPSULE5611
71610-315-53Pregabalin60 in 1 BOTTLECAPSULE6011
71610-315-70Pregabalin120 in 1 BOTTLECAPSULE12011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-315PREGABALIN CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]8Legacy NDC, 4 package rows20240305_bf710bcf-75ed-4184-b9c3-81cd05a780a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483440pregabalin 150 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483446pregabalin 200 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
577127pregabalin 225 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483442pregabalin 25 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483444pregabalin 300 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483448pregabalin 50 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483450pregabalin 75 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483438pregabalin 100 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483440pregabalin 150 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483446pregabalin 200 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
577127pregabalin 225 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483442pregabalin 25 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483444pregabalin 300 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483448pregabalin 50 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483450pregabalin 75 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-315-307161003153030 CAPSULE in 1 BOTTLE (71610-315-30) 30 capsule2019-08-120000-00-00NoNoCurrent
71610-315-467161003154656 CAPSULE in 1 BOTTLE (71610-315-46) 56 capsule2019-08-120000-00-00NoNoCurrent
71610-315-537161003155360 CAPSULE in 1 BOTTLE (71610-315-53) 60 capsule2019-08-120000-00-00NoNoCurrent
71610-315-7071610031570120 CAPSULE in 1 BOTTLE (71610-315-70) 120 capsule2019-08-120000-00-00NoNoCurrent