FDA.reportPublic FDA data

Pregabalin

Product NDC
67877-464
11-digit product format
678770464
Labeler code
67877
Product ID
67877-464_bf3e2485-edec-4163-b3ff-0e671f12df15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA207799
Marketing category
ANDA
Marketing start
2019-07-21
Substance
PREGABALIN
Active strength
75 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
PREGABALIN75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-464-05Pregabalin500 in 1 BOTTLECAPSULE50018
67877-464-30Pregabalin30 in 1 BOTTLECAPSULE3018
67877-464-33Pregabalin1 in 1 CARTONCAPSULE118
67877-464-33Pregabalin10 in 1 BLISTER PACKCAPSULE1018
67877-464-38Pregabalin10 in 1 CARTONCAPSULE1018
67877-464-38Pregabalin10 in 1 BLISTER PACKCAPSULE1018
67877-464-90Pregabalin90 in 1 BOTTLECAPSULE9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-464-05EA - Each67877-464b5d6d36e-28b5-4797-889a-8a99879f9fff12021-10-08
67877-464-90EA - Each67877-464798b3ebf-ee50-4c92-895c-01079c65b30212019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-464PREGABALIN CAPSULE [ASCEND LABORATORIES, LLC]16Current NDC, Legacy NDC, 7 package rows20240830_e48db3c2-7351-41f2-a451-5a8341c4125c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483450pregabalin 75 MG Oral CapsulePSNb5b22ec1-3fd8-4631-ba7e-98d8e5d030b3104
483450pregabalin 75 MG Oral CapsuleSCDb5b22ec1-3fd8-4631-ba7e-98d8e5d030b3104
483438pregabalin 100 MG Oral CapsulePSNe48db3c2-7351-41f2-a451-5a8341c4125c18
483440pregabalin 150 MG Oral CapsulePSNe48db3c2-7351-41f2-a451-5a8341c4125c18
483446pregabalin 200 MG Oral CapsulePSNe48db3c2-7351-41f2-a451-5a8341c4125c18
577127pregabalin 225 MG Oral CapsulePSNe48db3c2-7351-41f2-a451-5a8341c4125c18
483442pregabalin 25 MG Oral CapsulePSNe48db3c2-7351-41f2-a451-5a8341c4125c18
483444pregabalin 300 MG Oral CapsulePSNe48db3c2-7351-41f2-a451-5a8341c4125c18
483448pregabalin 50 MG Oral CapsulePSNe48db3c2-7351-41f2-a451-5a8341c4125c18
483450pregabalin 75 MG Oral CapsulePSNe48db3c2-7351-41f2-a451-5a8341c4125c18
483438pregabalin 100 MG Oral CapsuleSCDe48db3c2-7351-41f2-a451-5a8341c4125c18
483440pregabalin 150 MG Oral CapsuleSCDe48db3c2-7351-41f2-a451-5a8341c4125c18
483446pregabalin 200 MG Oral CapsuleSCDe48db3c2-7351-41f2-a451-5a8341c4125c18
577127pregabalin 225 MG Oral CapsuleSCDe48db3c2-7351-41f2-a451-5a8341c4125c18
483442pregabalin 25 MG Oral CapsuleSCDe48db3c2-7351-41f2-a451-5a8341c4125c18
483444pregabalin 300 MG Oral CapsuleSCDe48db3c2-7351-41f2-a451-5a8341c4125c18
483448pregabalin 50 MG Oral CapsuleSCDe48db3c2-7351-41f2-a451-5a8341c4125c18
483450pregabalin 75 MG Oral CapsuleSCDe48db3c2-7351-41f2-a451-5a8341c4125c18
483450pregabalin 75 MG Oral CapsulePSN12309847-0857-4ff7-a7e7-edeadc3dfb618
483450pregabalin 75 MG Oral CapsuleSCD12309847-0857-4ff7-a7e7-edeadc3dfb618
483440pregabalin 150 MG Oral CapsulePSNd2813712-d7f6-6144-e053-2995a90a3c5d7
483448pregabalin 50 MG Oral CapsulePSNd2813712-d7f6-6144-e053-2995a90a3c5d7
483450pregabalin 75 MG Oral CapsulePSNd2813712-d7f6-6144-e053-2995a90a3c5d7
483440pregabalin 150 MG Oral CapsuleSCDd2813712-d7f6-6144-e053-2995a90a3c5d7
483448pregabalin 50 MG Oral CapsuleSCDd2813712-d7f6-6144-e053-2995a90a3c5d7
483450pregabalin 75 MG Oral CapsuleSCDd2813712-d7f6-6144-e053-2995a90a3c5d7
483450pregabalin 75 MG Oral CapsulePSNa0da0534-b386-4c93-ae89-03b0e3325e023
483450pregabalin 75 MG Oral CapsuleSCDa0da0534-b386-4c93-ae89-03b0e3325e023
483450pregabalin 75 MG Oral CapsulePSNa1545bbb-b337-4760-ab4c-fb76ab0193372
483450pregabalin 75 MG Oral CapsuleSCDa1545bbb-b337-4760-ab4c-fb76ab0193372
483438pregabalin 100 MG Oral CapsulePSN613a7a13-d5ba-4827-91ec-3ed5176602b71
483440pregabalin 150 MG Oral CapsulePSN613a7a13-d5ba-4827-91ec-3ed5176602b71
483446pregabalin 200 MG Oral CapsulePSN613a7a13-d5ba-4827-91ec-3ed5176602b71
483448pregabalin 50 MG Oral CapsulePSN613a7a13-d5ba-4827-91ec-3ed5176602b71
483450pregabalin 75 MG Oral CapsulePSN613a7a13-d5ba-4827-91ec-3ed5176602b71
483438pregabalin 100 MG Oral CapsuleSCD613a7a13-d5ba-4827-91ec-3ed5176602b71
483440pregabalin 150 MG Oral CapsuleSCD613a7a13-d5ba-4827-91ec-3ed5176602b71
483446pregabalin 200 MG Oral CapsuleSCD613a7a13-d5ba-4827-91ec-3ed5176602b71
483448pregabalin 50 MG Oral CapsuleSCD613a7a13-d5ba-4827-91ec-3ed5176602b71
483450pregabalin 75 MG Oral CapsuleSCD613a7a13-d5ba-4827-91ec-3ed5176602b71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-464-0567877046405500 CAPSULE in 1 BOTTLE (67877-464-05) 500 capsule2019-07-210000-00-00NoNoCurrent
67877-464-306787704643030 CAPSULE in 1 BOTTLE (67877-464-30) 30 capsule2019-07-210000-00-00NoNoCurrent
67877-464-33678770464331 BLISTER PACK in 1 CARTON (67877-464-33) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2019-07-210000-00-00NoNoCurrent
67877-464-386787704643810 BLISTER PACK in 1 CARTON (67877-464-38) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2019-07-210000-00-00NoNoCurrent
67877-464-906787704649090 CAPSULE in 1 BOTTLE (67877-464-90) 90 capsule2019-07-210000-00-00NoNoCurrent