FDA.reportPublic FDA data

Pregabalin

Product NDC
73190-060
Requested package NDC
73190-060-50
11-digit product format
731900060
Labeler code
73190
Product ID
73190-060_458708b4-56b8-8d18-e063-6294a90a8c47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA212988
Marketing category
ANDA
Marketing start
2025-12-09
Substance
PREGABALIN
Active strength
300 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212988-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2022-03-08
A212988-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2022-03-08
A212988-003PREGABALINPREGABALIN75MGCAPSULE / ORALAB2022-03-08
A212988-004PREGABALINPREGABALIN100MGCAPSULE / ORALAB2022-03-08
A212988-005PREGABALINPREGABALIN150MGCAPSULE / ORALAB2022-03-08
A212988-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2022-03-08
A212988-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2022-03-08
A212988-008PREGABALINPREGABALIN300MGCAPSULE / ORALAB2022-03-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-productTE code
A212988-001AB
A212988-002AB
A212988-003AB
A212988-004AB
A212988-005AB
A212988-006AB
A212988-007AB
A212988-008AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A212988-001PREGABALIN25MGCAPSULE / ORALAB2022-03-08a50c72e98297…
2026-08-01 22:54:322026-06A212988-002PREGABALIN50MGCAPSULE / ORALAB2022-03-08a50c72e98297…
2026-08-01 22:54:322026-06A212988-003PREGABALIN75MGCAPSULE / ORALAB2022-03-08a50c72e98297…
2026-08-01 22:54:322026-06A212988-004PREGABALIN100MGCAPSULE / ORALAB2022-03-08a50c72e98297…
2026-08-01 22:54:322026-06A212988-005PREGABALIN150MGCAPSULE / ORALAB2022-03-08a50c72e98297…
2026-08-01 22:54:322026-06A212988-006PREGABALIN200MGCAPSULE / ORALAB2022-03-08a50c72e98297…
2026-08-01 22:54:322026-06A212988-007PREGABALIN225MGCAPSULE / ORALAB2022-03-08a50c72e98297…
2026-08-01 22:54:322026-06A212988-008PREGABALIN300MGCAPSULE / ORALAB2022-03-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212988-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A212988-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A212988-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A212988-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A212988-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A212988-006AB1a50c72e98297…
2026-08-01 22:54:322026-06A212988-007AB1a50c72e98297…
2026-08-01 22:54:322026-06A212988-008AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINProficient Rx LP189b610e-3e29-42fa-ab6e-73effbe0d0542026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212988
application number: ANDA212988
PregabalinPREGABALINProficient Rx LP34846423-e747-42c5-9bcd-f99c557c4f672026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212988
application number: ANDA212988
PREGABALINPREGABALINEskayef Pharmaceuticals Limited65d9e751-61c2-4741-85c0-2526cfdc765c2025-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212988
application number: ANDA212988
PregabalinPREGABALINAvKARE458705af-06fa-57d1-e063-6394a90a3b2e2025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212988
application number: ANDA212988
ndc (package): 73190-060-50
ndc (product): 73190-060
ndc11 (package): 73190006050
PregabalinPREGABALINWestminster Pharmaceuticals, LLC6b0ee2cf-52c3-4052-bea0-1458a42337452025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212988
application number: ANDA212988

Additional Listing Data#

Finished product
Yes
Brand name base
Pregabalin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
55JG375S6MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
483438Internal RxNorm lookup
483440Internal RxNorm lookup
483442Internal RxNorm lookup
483444Internal RxNorm lookup
483446Internal RxNorm lookup
483448Internal RxNorm lookup
483450Internal RxNorm lookup
577127Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
458705af-06fa-57d1-e063-6394a90a3b2eAvailable on FDA.report

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
73190-060-50Pregabalin500 in 1 BOTTLECAPSULE5001
73190-060-90Pregabalin90 in 1 BOTTLECAPSULE901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN458705af-06fa-57d1-e063-6394a90a3b2e1
483440pregabalin 150 MG Oral CapsulePSN458705af-06fa-57d1-e063-6394a90a3b2e1
483446pregabalin 200 MG Oral CapsulePSN458705af-06fa-57d1-e063-6394a90a3b2e1
577127pregabalin 225 MG Oral CapsulePSN458705af-06fa-57d1-e063-6394a90a3b2e1
483442pregabalin 25 MG Oral CapsulePSN458705af-06fa-57d1-e063-6394a90a3b2e1
483444pregabalin 300 MG Oral CapsulePSN458705af-06fa-57d1-e063-6394a90a3b2e1
483448pregabalin 50 MG Oral CapsulePSN458705af-06fa-57d1-e063-6394a90a3b2e1
483450pregabalin 75 MG Oral CapsulePSN458705af-06fa-57d1-e063-6394a90a3b2e1
483438pregabalin 100 MG Oral CapsuleSCD458705af-06fa-57d1-e063-6394a90a3b2e1
483440pregabalin 150 MG Oral CapsuleSCD458705af-06fa-57d1-e063-6394a90a3b2e1
483446pregabalin 200 MG Oral CapsuleSCD458705af-06fa-57d1-e063-6394a90a3b2e1
577127pregabalin 225 MG Oral CapsuleSCD458705af-06fa-57d1-e063-6394a90a3b2e1
483442pregabalin 25 MG Oral CapsuleSCD458705af-06fa-57d1-e063-6394a90a3b2e1
483444pregabalin 300 MG Oral CapsuleSCD458705af-06fa-57d1-e063-6394a90a3b2e1
483448pregabalin 50 MG Oral CapsuleSCD458705af-06fa-57d1-e063-6394a90a3b2e1
483450pregabalin 75 MG Oral CapsuleSCD458705af-06fa-57d1-e063-6394a90a3b2e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73190-060-5073190006050500 CAPSULE in 1 BOTTLE (73190-060-50) 500 capsule2025-12-09NoNoCurrent