FDA.reportPublic FDA data

PREGABALIN capsules, CV

Product NDC
69097-678
11-digit product format
690970678
Labeler code
69097
Product ID
69097-678_22a469ee-1346-4abb-84f1-4c2caf26437b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN capsules, CV
Dosage form
CAPSULE
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA212280
Marketing category
ANDA
Marketing start
2020-01-10
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 capsules, CV
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
69097-678-02PREGABALIN capsules, CV30 in 1 BOTTLECAPSULE309
69097-678-05PREGABALIN capsules, CV90 in 1 BOTTLECAPSULE909
69097-678-12PREGABALIN capsules, CV500 in 1 BOTTLECAPSULE5009
69097-678-19PREGABALIN capsules, CV10 in 1 BLISTER PACKCAPSULE109
69097-678-21PREGABALIN capsules, CV100 in 1 CARTONCAPSULE1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-678PREGABALIN CAPSULES, CV CAPSULE [CIPLA USA INC.]7Current NDC, Legacy NDC, 5 package rows20211123_7d93359c-1849-430d-a922-21d42932d0f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN7d93359c-1849-430d-a922-21d42932d0f39
483440pregabalin 150 MG Oral CapsulePSN7d93359c-1849-430d-a922-21d42932d0f39
483446pregabalin 200 MG Oral CapsulePSN7d93359c-1849-430d-a922-21d42932d0f39
577127pregabalin 225 MG Oral CapsulePSN7d93359c-1849-430d-a922-21d42932d0f39
483442pregabalin 25 MG Oral CapsulePSN7d93359c-1849-430d-a922-21d42932d0f39
483444pregabalin 300 MG Oral CapsulePSN7d93359c-1849-430d-a922-21d42932d0f39
483448pregabalin 50 MG Oral CapsulePSN7d93359c-1849-430d-a922-21d42932d0f39
483450pregabalin 75 MG Oral CapsulePSN7d93359c-1849-430d-a922-21d42932d0f39
483438pregabalin 100 MG Oral CapsuleSCD7d93359c-1849-430d-a922-21d42932d0f39
483440pregabalin 150 MG Oral CapsuleSCD7d93359c-1849-430d-a922-21d42932d0f39
483446pregabalin 200 MG Oral CapsuleSCD7d93359c-1849-430d-a922-21d42932d0f39
577127pregabalin 225 MG Oral CapsuleSCD7d93359c-1849-430d-a922-21d42932d0f39
483442pregabalin 25 MG Oral CapsuleSCD7d93359c-1849-430d-a922-21d42932d0f39
483444pregabalin 300 MG Oral CapsuleSCD7d93359c-1849-430d-a922-21d42932d0f39
483448pregabalin 50 MG Oral CapsuleSCD7d93359c-1849-430d-a922-21d42932d0f39
483450pregabalin 75 MG Oral CapsuleSCD7d93359c-1849-430d-a922-21d42932d0f39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-678-026909706780230 CAPSULE in 1 BOTTLE (69097-678-02) 30 capsule2020-01-100000-00-00NoNoCurrent
69097-678-056909706780590 CAPSULE in 1 BOTTLE (69097-678-05) 90 capsule2020-01-100000-00-00NoNoCurrent
69097-678-1269097067812500 CAPSULE in 1 BOTTLE (69097-678-12) 500 capsule2020-01-100000-00-00NoNoCurrent
69097-678-196909706781910 in 1 BLISTER PACKHistorical
69097-678-2169097067821100 BLISTER PACK in 1 CARTON (69097-678-21) > 10 CAPSULE in 1 BLISTER PACK (69097-678-19) 100 blister pack2020-01-100000-00-00NoNoCurrent