pregabalin

Product NDC
43598-292
11-digit product format
435980292
Labeler code
43598
Product ID
43598-292_4a1e5038-d049-606f-c087-48bc353a8a69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Dr.Reddys Laboratories Inc
Application
ANDA209664
Marketing category
ANDA
Marketing start
2019-07-19
Substance
PREGABALIN
Active strength
50 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
PREGABALIN50 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
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-292-05pregabalin500 in 1 BOTTLECAPSULE50013
43598-292-66pregabalin5 in 1 CARTONCAPSULE513
43598-292-78pregabalin10 in 1 CARTONCAPSULE1013
43598-292-79pregabalin10 in 1 BLISTER PACKCAPSULE1013
43598-292-90pregabalin90 in 1 BOTTLECAPSULE9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-292-66EA - Each43598-292027efe4d-6579-4d95-9811-db3e5222021212020-01-03
43598-292-79EA - Each43598-2920ebdbdce-4997-417c-bf07-080e8d9de27412020-02-13
43598-292-90EA - Each43598-29208a0e126-a737-42ed-ac63-211741ed4d2d12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-292PREGABALIN CAPSULE [DR.REDDYS LABORATORIES INC]12Current NDC, Legacy NDC, 5 package rows20240228_ceed457b-8f43-4021-fd70-071c96e09470.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSNceed457b-8f43-4021-fd70-071c96e0947013
483440pregabalin 150 MG Oral CapsulePSNceed457b-8f43-4021-fd70-071c96e0947013
483446pregabalin 200 MG Oral CapsulePSNceed457b-8f43-4021-fd70-071c96e0947013
577127pregabalin 225 MG Oral CapsulePSNceed457b-8f43-4021-fd70-071c96e0947013
483442pregabalin 25 MG Oral CapsulePSNceed457b-8f43-4021-fd70-071c96e0947013
483444pregabalin 300 MG Oral CapsulePSNceed457b-8f43-4021-fd70-071c96e0947013
483448pregabalin 50 MG Oral CapsulePSNceed457b-8f43-4021-fd70-071c96e0947013
483450pregabalin 75 MG Oral CapsulePSNceed457b-8f43-4021-fd70-071c96e0947013
483438pregabalin 100 MG Oral CapsuleSCDceed457b-8f43-4021-fd70-071c96e0947013
483440pregabalin 150 MG Oral CapsuleSCDceed457b-8f43-4021-fd70-071c96e0947013
483446pregabalin 200 MG Oral CapsuleSCDceed457b-8f43-4021-fd70-071c96e0947013
577127pregabalin 225 MG Oral CapsuleSCDceed457b-8f43-4021-fd70-071c96e0947013
483442pregabalin 25 MG Oral CapsuleSCDceed457b-8f43-4021-fd70-071c96e0947013
483444pregabalin 300 MG Oral CapsuleSCDceed457b-8f43-4021-fd70-071c96e0947013
483448pregabalin 50 MG Oral CapsuleSCDceed457b-8f43-4021-fd70-071c96e0947013
483450pregabalin 75 MG Oral CapsuleSCDceed457b-8f43-4021-fd70-071c96e0947013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-292-0543598029205500 CAPSULE in 1 BOTTLE (43598-292-05) 500 capsule2019-07-190000-00-00NoNoCurrent
43598-292-66435980292665 BLISTER PACK in 1 CARTON (43598-292-66) / 10 CAPSULE in 1 BLISTER PACK (43598-292-79) 5 blister pack2019-07-190000-00-00NoNoCurrent
43598-292-784359802927810 BLISTER PACK in 1 CARTON (43598-292-78) / 10 CAPSULE in 1 BLISTER PACK (43598-292-79) 10 blister pack2019-07-190000-00-00NoNoCurrent
43598-292-794359802927910 in 1 BLISTER PACKHistorical
43598-292-904359802929090 CAPSULE in 1 BOTTLE (43598-292-90) 90 capsule2019-07-190000-00-00NoNoCurrent