FDA.reportPublic FDA data

Pregabalin

Product NDC
71335-1745
11-digit product format
713351745
Labeler code
71335
Product ID
71335-1745_db23090f-cc98-4f5c-9a82-32ad5bb106bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207799
Marketing category
ANDA
Marketing start
2019-07-21
Substance
PREGABALIN
Active strength
150 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
PREGABALIN150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483440

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1745-12024-04-08C16284748780-11030e365-6238-111a-e063-dadaa90a10e2These 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
71335-1745-22024-04-08C16284748780-11030e365-6238-111a-e063-dadaa90a10e2These 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
71335-1745-32024-04-08C16284748780-11030e365-6238-111a-e063-dadaa90a10e2These 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
71335-1745-42024-04-08C16284748780-11030e365-6238-111a-e063-dadaa90a10e2These 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
71335-1745-12024-01-30C16284748780-11030e365-6238-111a-e063-dadaa90a10e2These 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
71335-1745-22024-01-30C16284748780-11030e365-6238-111a-e063-dadaa90a10e2These 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
71335-1745-32024-01-30C16284748780-11030e365-6238-111a-e063-dadaa90a10e2These 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
71335-1745-42024-01-30C16284748780-11030e365-6238-111a-e063-dadaa90a10e2These 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
71335-1745-1Pregabalin30 in 1 BOTTLECAPSULE30104
71335-1745-2Pregabalin60 in 1 BOTTLECAPSULE60104
71335-1745-3Pregabalin90 in 1 BOTTLECAPSULE90104
71335-1745-4Pregabalin180 in 1 BOTTLECAPSULE180104
71335-1745-5Pregabalin120 in 1 BOTTLECAPSULE120104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1745-1EA - Each71335-1745b02f954e-9f20-45c0-a0c9-46a9b0bbce9e12021-07-15
71335-1745-2EA - Each71335-1745c73ac0ce-e7f1-4a97-bca3-da898eb666db12021-07-15
71335-1745-3EA - Each71335-1745b915122a-0dfd-4aef-961d-029d49d9d31612021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1745PREGABALIN CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 5 package rows20240915_08ad87e3-e00c-46d1-98f8-df493cf1712e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483440pregabalin 150 MG Oral CapsulePSN08ad87e3-e00c-46d1-98f8-df493cf1712e104
483440pregabalin 150 MG Oral CapsuleSCD08ad87e3-e00c-46d1-98f8-df493cf1712e104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1745-17133517450130 CAPSULE in 1 BOTTLE (71335-1745-1) 30 capsule2021-01-060000-00-00NoNoCurrent
71335-1745-27133517450260 CAPSULE in 1 BOTTLE (71335-1745-2) 60 capsule2020-12-300000-00-00NoNoCurrent
71335-1745-37133517450390 CAPSULE in 1 BOTTLE (71335-1745-3) 90 capsule2020-12-220000-00-00NoNoCurrent
71335-1745-471335174504180 CAPSULE in 1 BOTTLE (71335-1745-4) 180 capsule2024-09-060000-00-00NoNoCurrent
71335-1745-571335174505120 CAPSULE in 1 BOTTLE (71335-1745-5) 120 capsule2024-09-06NoNoCurrent