PREGABALIN

Product NDC
82619-129
11-digit product format
826190129
Labeler code
82619
Product ID
82619-129_40b92ce3-6161-36b7-e063-6394a90af51e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Creekwood Pharmaceuticals LLC
Application
ANDA213423
Marketing category
ANDA
Marketing start
2024-09-20
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 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
A213423-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2020-03-23
A213423-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2020-03-23
A213423-003PREGABALINPREGABALIN75MGCAPSULE / ORALAB2020-03-23
A213423-004PREGABALINPREGABALIN100MGCAPSULE / ORALAB2020-03-23
A213423-005PREGABALINPREGABALIN150MGCAPSULE / ORALAB2020-03-23
A213423-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2020-03-23
A213423-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2020-03-23
A213423-008PREGABALINPREGABALIN300MGCAPSULE / ORALAB2020-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213423-001AB
A213423-002AB
A213423-003AB
A213423-004AB
A213423-005AB
A213423-006AB
A213423-007AB
A213423-008AB

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 8 · 312 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213423-001PREGABALIN25MGCAPSULE / ORALAB2020-03-2384e616aacf4f…
2026-09-14 22:38:342026-08A213423-002PREGABALIN50MGCAPSULE / ORALAB2020-03-2384e616aacf4f…
2026-09-14 22:38:342026-08A213423-003PREGABALIN75MGCAPSULE / ORALAB2020-03-2384e616aacf4f…
2026-09-14 22:38:342026-08A213423-004PREGABALIN100MGCAPSULE / ORALAB2020-03-2384e616aacf4f…
2026-09-14 22:38:342026-08A213423-005PREGABALIN150MGCAPSULE / ORALAB2020-03-2384e616aacf4f…
2026-09-14 22:38:342026-08A213423-006PREGABALIN200MGCAPSULE / ORALAB2020-03-2384e616aacf4f…
2026-09-14 22:38:342026-08A213423-007PREGABALIN225MGCAPSULE / ORALAB2020-03-2384e616aacf4f…
2026-09-14 22:38:342026-08A213423-008PREGABALIN300MGCAPSULE / ORALAB2020-03-2384e616aacf4f…
2026-08-18 06:07:402026-07A213423-001PREGABALIN25MGCAPSULE / ORALAB2020-03-23caaa826d4ba7…
2026-08-18 06:07:402026-07A213423-002PREGABALIN50MGCAPSULE / ORALAB2020-03-23caaa826d4ba7…
2026-08-18 06:07:402026-07A213423-003PREGABALIN75MGCAPSULE / ORALAB2020-03-23caaa826d4ba7…
2026-08-18 06:07:402026-07A213423-004PREGABALIN100MGCAPSULE / ORALAB2020-03-23caaa826d4ba7…
2026-08-18 06:07:402026-07A213423-005PREGABALIN150MGCAPSULE / ORALAB2020-03-23caaa826d4ba7…
2026-08-18 06:07:402026-07A213423-006PREGABALIN200MGCAPSULE / ORALAB2020-03-23caaa826d4ba7…
2026-08-18 06:07:402026-07A213423-007PREGABALIN225MGCAPSULE / ORALAB2020-03-23caaa826d4ba7…
2026-08-18 06:07:402026-07A213423-008PREGABALIN300MGCAPSULE / ORALAB2020-03-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213423-001PREGABALIN25MGCAPSULE / ORALAB2020-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213423-002PREGABALIN50MGCAPSULE / ORALAB2020-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213423-003PREGABALIN75MGCAPSULE / ORALAB2020-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213423-004PREGABALIN100MGCAPSULE / ORALAB2020-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213423-005PREGABALIN150MGCAPSULE / ORALAB2020-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213423-006PREGABALIN200MGCAPSULE / ORALAB2020-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213423-007PREGABALIN225MGCAPSULE / ORALAB2020-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213423-008PREGABALIN300MGCAPSULE / ORALAB2020-03-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213423-001PREGABALIN25MGCAPSULE / ORALAB2020-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213423-002PREGABALIN50MGCAPSULE / ORALAB2020-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213423-003PREGABALIN75MGCAPSULE / ORALAB2020-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213423-004PREGABALIN100MGCAPSULE / ORALAB2020-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213423-005PREGABALIN150MGCAPSULE / ORALAB2020-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213423-006PREGABALIN200MGCAPSULE / ORALAB2020-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213423-007PREGABALIN225MGCAPSULE / ORALAB2020-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213423-008PREGABALIN300MGCAPSULE / ORALAB2020-03-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A213423-001PREGABALIN25MGCAPSULE / ORALAB2020-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213423-002PREGABALIN50MGCAPSULE / ORALAB2020-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213423-003PREGABALIN75MGCAPSULE / ORALAB2020-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213423-004PREGABALIN100MGCAPSULE / ORALAB2020-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213423-005PREGABALIN150MGCAPSULE / ORALAB2020-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213423-006PREGABALIN200MGCAPSULE / ORALAB2020-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213423-007PREGABALIN225MGCAPSULE / ORALAB2020-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213423-008PREGABALIN300MGCAPSULE / ORALAB2020-03-236a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 312 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A213423-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A213423-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A213423-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A213423-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A213423-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A213423-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A213423-007AB184e616aacf4f…
2026-09-14 22:38:342026-08A213423-008AB184e616aacf4f…
2026-08-18 06:07:402026-07A213423-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213423-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213423-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213423-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213423-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213423-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213423-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213423-008AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213423-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213423-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213423-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213423-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213423-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213423-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213423-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213423-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213423-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213423-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213423-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213423-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213423-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213423-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213423-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213423-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213423-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213423-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213423-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213423-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213423-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213423-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213423-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213423-008AB16a471c1ec25d…

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
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
bfe4108e-b2d2-4059-be16-21d3276c3ae4Available 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
82619-129-01PREGABALIN90 in 1 BOTTLECAPSULE905
82619-129-02PREGABALIN500 in 1 BOTTLECAPSULE5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82619-129-01EA - Each82619-12911b25af5-0ad8-4450-bbb0-98f6d53ac01f12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82619-129PREGABALIN CAPSULE [CREEKWOOD PHARMACEUTICALS LLC]1Current NDC, 2 package rows20240920_bfe4108e-b2d2-4059-be16-21d3276c3ae4.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREGABALINPREGABALINCreekwood Pharmaceuticals LLCbfe4108e-b2d2-4059-be16-21d3276c3ae42025-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213423
application number: ANDA213423
ndc (product): 82619-129

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSNbfe4108e-b2d2-4059-be16-21d3276c3ae45
483440pregabalin 150 MG Oral CapsulePSNbfe4108e-b2d2-4059-be16-21d3276c3ae45
483446pregabalin 200 MG Oral CapsulePSNbfe4108e-b2d2-4059-be16-21d3276c3ae45
577127pregabalin 225 MG Oral CapsulePSNbfe4108e-b2d2-4059-be16-21d3276c3ae45
483442pregabalin 25 MG Oral CapsulePSNbfe4108e-b2d2-4059-be16-21d3276c3ae45
483444pregabalin 300 MG Oral CapsulePSNbfe4108e-b2d2-4059-be16-21d3276c3ae45
483448pregabalin 50 MG Oral CapsulePSNbfe4108e-b2d2-4059-be16-21d3276c3ae45
483450pregabalin 75 MG Oral CapsulePSNbfe4108e-b2d2-4059-be16-21d3276c3ae45
483438pregabalin 100 MG Oral CapsuleSCDbfe4108e-b2d2-4059-be16-21d3276c3ae45
483440pregabalin 150 MG Oral CapsuleSCDbfe4108e-b2d2-4059-be16-21d3276c3ae45
483446pregabalin 200 MG Oral CapsuleSCDbfe4108e-b2d2-4059-be16-21d3276c3ae45
577127pregabalin 225 MG Oral CapsuleSCDbfe4108e-b2d2-4059-be16-21d3276c3ae45
483442pregabalin 25 MG Oral CapsuleSCDbfe4108e-b2d2-4059-be16-21d3276c3ae45
483444pregabalin 300 MG Oral CapsuleSCDbfe4108e-b2d2-4059-be16-21d3276c3ae45
483448pregabalin 50 MG Oral CapsuleSCDbfe4108e-b2d2-4059-be16-21d3276c3ae45
483450pregabalin 75 MG Oral CapsuleSCDbfe4108e-b2d2-4059-be16-21d3276c3ae45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82619-129-018261901290190 CAPSULE in 1 BOTTLE (82619-129-01) 90 capsule2024-09-20NoNoCurrent
82619-129-0282619012902500 CAPSULE in 1 BOTTLE (82619-129-02) 500 capsule2024-09-20NoNoCurrent