FDA.reportPublic FDA data

Pregabalin

Product NDC
69367-327
11-digit product format
693670327
Labeler code
69367
Product ID
69367-327_0efc2eea-ebae-47f9-a13a-f2df4331cf04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA208677
Marketing category
ANDA
Marketing start
2021-08-24
Substance
PREGABALIN
Active strength
100 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 43.

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
A208677-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2019-07-19
A208677-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2019-07-19
A208677-003PREGABALINPREGABALIN75MGCAPSULE / ORALAB2019-07-19
A208677-004PREGABALINPREGABALIN100MGCAPSULE / ORALAB2019-07-19
A208677-005PREGABALINPREGABALIN150MGCAPSULE / ORALAB2019-07-19
A208677-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2019-07-19
A208677-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2019-07-19
A208677-008PREGABALINPREGABALIN300MGCAPSULE / ORALAB2019-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208677-001AB
A208677-002AB
A208677-003AB
A208677-004AB
A208677-005AB
A208677-006AB
A208677-007AB
A208677-008AB

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.

Product history page 1 of 9 · 336 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-08-18 06:07:402026-07A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A208677-001PREGABALIN25MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-002PREGABALIN50MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-003PREGABALIN75MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-004PREGABALIN100MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-005PREGABALIN150MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-006PREGABALIN200MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-007PREGABALIN225MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-008PREGABALIN300MGCAPSULE / ORALAB2019-07-196a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 336 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208677-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-007AB184e616aacf4f…
2026-09-14 22:38:342026-08A208677-008AB184e616aacf4f…
2026-08-18 06:07:402026-07A208677-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208677-008AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208677-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208677-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208677-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208677-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208677-008AB16a471c1ec25d…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 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
781cb1ac-a0d2-4b47-b319-f0b90de86384Available 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
69367-327-09Pregabalin90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-327-09EA - Each69367-32754cfb9f2-3826-4d59-acae-6d92cfb8143f12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-327PREGABALIN CAPSULE [WESTMINSTER PHARMACEUTICALS, LLC]2Current NDC, Legacy NDC, 1 package rows20240405_781cb1ac-a0d2-4b47-b319-f0b90de86384.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 5 · 87 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINBryant Ranch Prepackc60f6b1e-7a24-41b2-8435-e20583a732c62026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack52e36f66-4c4a-4fc5-968b-46879b7bf1db2026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepackdf382975-73f1-4957-8959-177848f796f72026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack90b65884-4222-4011-b042-88b83e51c57a2026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepackdbf3647a-5ab1-450e-be5f-69b8441855722026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepackbe8d51d7-ae26-4fc7-9457-a4ad84523fd72026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack9053ff4e-cc47-4fa8-990a-4b0d539a480a2026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack36085f4e-91ae-458c-b0a0-81363112df012026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINBryant Ranch Prepack47cc53e6-e679-4a01-babc-af301dd756f72026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4db38263-899a-8405-e063-6294a90a44082026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4ddf514f-3922-624b-e063-6394a90a8f6b2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4ddf7b9b-7b72-913c-e063-6394a90af3a42026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4db84135-4e89-0f23-e063-6394a90a9b9b2026-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINA-S Medication Solutions55b62778-0e6a-45e8-9ace-3f1d6eca44872026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC99c3d252-4d51-4679-aa61-e2d0b8238b382026-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINGolden State Medical Supply, Inc.1ef735e8-467e-ed0d-e063-6294a90a210e2025-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINScieGen Pharmaceuticals, Inc459f0d31-a73f-2c62-e063-6394a90a810c2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC14c00449-c3b8-d6ba-e063-6294a90ab6272025-10-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINScieGen Pharmaceuticals, Inc33ef1a3b-554f-4a51-afdb-92a019e8c16c2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
PregabalinPREGABALINWestminster Pharmaceuticals, LLC781cb1ac-a0d2-4b47-b319-f0b90de863842025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208677
application number: ANDA208677
ndc (product): 69367-327

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN781cb1ac-a0d2-4b47-b319-f0b90de863843
483440pregabalin 150 MG Oral CapsulePSN781cb1ac-a0d2-4b47-b319-f0b90de863843
483446pregabalin 200 MG Oral CapsulePSN781cb1ac-a0d2-4b47-b319-f0b90de863843
577127pregabalin 225 MG Oral CapsulePSN781cb1ac-a0d2-4b47-b319-f0b90de863843
483442pregabalin 25 MG Oral CapsulePSN781cb1ac-a0d2-4b47-b319-f0b90de863843
483444pregabalin 300 MG Oral CapsulePSN781cb1ac-a0d2-4b47-b319-f0b90de863843
483448pregabalin 50 MG Oral CapsulePSN781cb1ac-a0d2-4b47-b319-f0b90de863843
483450pregabalin 75 MG Oral CapsulePSN781cb1ac-a0d2-4b47-b319-f0b90de863843
483438pregabalin 100 MG Oral CapsuleSCD781cb1ac-a0d2-4b47-b319-f0b90de863843
483440pregabalin 150 MG Oral CapsuleSCD781cb1ac-a0d2-4b47-b319-f0b90de863843
483446pregabalin 200 MG Oral CapsuleSCD781cb1ac-a0d2-4b47-b319-f0b90de863843
577127pregabalin 225 MG Oral CapsuleSCD781cb1ac-a0d2-4b47-b319-f0b90de863843
483442pregabalin 25 MG Oral CapsuleSCD781cb1ac-a0d2-4b47-b319-f0b90de863843
483444pregabalin 300 MG Oral CapsuleSCD781cb1ac-a0d2-4b47-b319-f0b90de863843
483448pregabalin 50 MG Oral CapsuleSCD781cb1ac-a0d2-4b47-b319-f0b90de863843
483450pregabalin 75 MG Oral CapsuleSCD781cb1ac-a0d2-4b47-b319-f0b90de863843
483438pregabalin 100 MG Oral CapsulePSN9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483438pregabalin 100 MG Oral CapsulePSN32789571-a566-46fa-ba41-bd3c86276ecf2
483438pregabalin 100 MG Oral CapsulePSN31e7caf6-0a8b-f343-e063-6294a90ad7292
483440pregabalin 150 MG Oral CapsulePSN9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483446pregabalin 200 MG Oral CapsulePSN9b1472ac-8b79-4f22-ae50-3b0942bd62b12
577127pregabalin 225 MG Oral CapsulePSN9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483442pregabalin 25 MG Oral CapsulePSN9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483444pregabalin 300 MG Oral CapsulePSN9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483448pregabalin 50 MG Oral CapsulePSN9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483450pregabalin 75 MG Oral CapsulePSN9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483438pregabalin 100 MG Oral CapsuleSCD9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483438pregabalin 100 MG Oral CapsuleSCD32789571-a566-46fa-ba41-bd3c86276ecf2
483438pregabalin 100 MG Oral CapsuleSCD31e7caf6-0a8b-f343-e063-6294a90ad7292
483440pregabalin 150 MG Oral CapsuleSCD9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483446pregabalin 200 MG Oral CapsuleSCD9b1472ac-8b79-4f22-ae50-3b0942bd62b12
577127pregabalin 225 MG Oral CapsuleSCD9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483442pregabalin 25 MG Oral CapsuleSCD9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483444pregabalin 300 MG Oral CapsuleSCD9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483448pregabalin 50 MG Oral CapsuleSCD9b1472ac-8b79-4f22-ae50-3b0942bd62b12
483450pregabalin 75 MG Oral CapsuleSCD9b1472ac-8b79-4f22-ae50-3b0942bd62b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-327-096936703270990 CAPSULE in 1 BOTTLE (69367-327-09) 90 capsule2021-08-240000-00-00NoNoCurrent