FDA.reportPublic FDA data

Pregabalin

Product NDC
67877-465
11-digit product format
678770465
Labeler code
67877
Product ID
67877-465_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
100 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
PREGABALIN100 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
67877-465-05Pregabalin500 in 1 BOTTLECAPSULE50018
67877-465-30Pregabalin30 in 1 BOTTLECAPSULE3018
67877-465-33Pregabalin10 in 1 BLISTER PACKCAPSULE1018
67877-465-33Pregabalin1 in 1 CARTONCAPSULE118
67877-465-38Pregabalin10 in 1 BLISTER PACKCAPSULE1018
67877-465-38Pregabalin10 in 1 CARTONCAPSULE1018
67877-465-90Pregabalin90 in 1 BOTTLECAPSULE9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-465-05EA - Each67877-4655f57a174-b26b-4294-993c-b6be74b40bc012021-10-08
67877-465-90EA - Each67877-4653741aeb9-7f07-4f35-9a5d-87c9d2e2f41412019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-465PREGABALIN 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
483438pregabalin 100 MG Oral CapsulePSNcf7f0fd0-bac2-4836-9363-79d32ad0cc10104
483438pregabalin 100 MG Oral CapsuleSCDcf7f0fd0-bac2-4836-9363-79d32ad0cc10104
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
483438pregabalin 100 MG Oral CapsulePSN3c8ea6da-5771-4096-a915-700e51ced05c8
483438pregabalin 100 MG Oral CapsuleSCD3c8ea6da-5771-4096-a915-700e51ced05c8
483438pregabalin 100 MG Oral CapsulePSNe8e272a4-c181-4573-822b-2bb315b6ad373
483438pregabalin 100 MG Oral CapsuleSCDe8e272a4-c181-4573-822b-2bb315b6ad373
483438pregabalin 100 MG Oral CapsulePSN1503dd3b-688b-4702-8fc1-954b5ffe42352
483438pregabalin 100 MG Oral CapsuleSCD1503dd3b-688b-4702-8fc1-954b5ffe42352
483438pregabalin 100 MG Oral CapsulePSN613a7a13-d5ba-4827-91ec-3ed5176602b71
483438pregabalin 100 MG Oral CapsulePSN35d3486c-c6ea-4d31-e063-6294a90a12191
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
483438pregabalin 100 MG Oral CapsuleSCD35d3486c-c6ea-4d31-e063-6294a90a12191
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
67877-465-0567877046505500 CAPSULE in 1 BOTTLE (67877-465-05) 500 capsule2019-07-210000-00-00NoNoCurrent
67877-465-306787704653030 CAPSULE in 1 BOTTLE (67877-465-30) 30 capsule2019-07-210000-00-00NoNoCurrent
67877-465-33678770465331 BLISTER PACK in 1 CARTON (67877-465-33) / 10 CAPSULE in 1 BLISTER PACK1 blister pack2019-07-210000-00-00NoNoCurrent
67877-465-386787704653810 BLISTER PACK in 1 CARTON (67877-465-38) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2019-07-210000-00-00NoNoCurrent
67877-465-906787704659090 CAPSULE in 1 BOTTLE (67877-465-90) 90 capsule2019-07-210000-00-00NoNoCurrent