Pregabalin

Product NDC
76282-568
11-digit product format
762820568
Labeler code
76282
Product ID
76282-568_b26b72af-62e4-4eb5-9cb8-e4eb05a22435
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Exelan Pharmaceuticals Inc.
Application
ANDA211384
Marketing category
ANDA
Marketing start
2019-07-19
Substance
PREGABALIN
Active strength
25 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
A211384-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2019-07-19
A211384-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2019-07-19
A211384-003PREGABALINPREGABALIN75MGCAPSULE / ORALAB2019-07-19
A211384-004PREGABALINPREGABALIN100MGCAPSULE / ORALAB2019-07-19
A211384-005PREGABALINPREGABALIN150MGCAPSULE / ORALAB2019-07-19
A211384-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2019-07-19
A211384-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2019-07-19
A211384-008PREGABALINPREGABALIN300MGCAPSULE / 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
A211384-001AB
A211384-002AB
A211384-003AB
A211384-004AB
A211384-005AB
A211384-006AB
A211384-007AB
A211384-008AB

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 22:38:342026-08A211384-001PREGABALIN25MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A211384-002PREGABALIN50MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A211384-003PREGABALIN75MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A211384-004PREGABALIN100MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A211384-005PREGABALIN150MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A211384-006PREGABALIN200MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A211384-007PREGABALIN225MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-09-14 22:38:342026-08A211384-008PREGABALIN300MGCAPSULE / ORALAB2019-07-1984e616aacf4f…
2026-08-18 06:07:402026-07A211384-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A211384-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A211384-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A211384-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A211384-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A211384-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A211384-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A211384-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211384-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211384-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211384-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211384-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211384-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211384-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211384-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211384-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211384-001PREGABALIN25MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211384-002PREGABALIN50MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211384-003PREGABALIN75MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211384-004PREGABALIN100MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211384-005PREGABALIN150MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211384-006PREGABALIN200MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211384-007PREGABALIN225MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211384-008PREGABALIN300MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A211384-001PREGABALIN25MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211384-002PREGABALIN50MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211384-003PREGABALIN75MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211384-004PREGABALIN100MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211384-005PREGABALIN150MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211384-006PREGABALIN200MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211384-007PREGABALIN225MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211384-008PREGABALIN300MGCAPSULE / 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 22:38:342026-08A211384-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A211384-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A211384-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A211384-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A211384-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A211384-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A211384-007AB184e616aacf4f…
2026-09-14 22:38:342026-08A211384-008AB184e616aacf4f…
2026-08-18 06:07:402026-07A211384-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211384-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211384-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211384-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211384-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211384-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211384-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211384-008AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211384-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211384-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211384-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211384-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211384-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211384-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211384-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211384-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211384-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211384-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211384-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211384-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211384-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211384-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211384-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211384-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211384-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211384-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211384-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211384-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211384-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211384-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211384-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211384-008AB16a471c1ec25d…

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
PREGABALIN25 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
3fdc6e94-2504-416c-81dd-2db9bc194ebbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-568-05Pregabalin500 in 1 BOTTLECAPSULE5005
76282-568-90Pregabalin90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-568-90EA - Each76282-5683c93f191-a8f3-4ec8-8ad5-bb6d7f85c16612019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-568PREGABALIN CAPSULE [EXELAN PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20230324_3fdc6e94-2504-416c-81dd-2db9bc194ebb.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCbf710bcf-75ed-4184-b9c3-81cd05a780a42025-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211384
application number: ANDA211384
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCef7c2e2c-c314-4bfd-a9fa-39f0b0884d342025-07-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211384
application number: ANDA211384
PregabalinPREGABALINCipla USA, Inc.17a8087c-579f-42de-ae92-006ea64def2a2025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211384
application number: ANDA211384
PregabalinPREGABALINExelan Pharmaceuticals Inc.3fdc6e94-2504-416c-81dd-2db9bc194ebb2025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211384
application number: ANDA211384
ndc (product): 76282-568

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483440pregabalin 150 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483446pregabalin 200 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
577127pregabalin 225 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483442pregabalin 25 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483444pregabalin 300 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483448pregabalin 50 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483450pregabalin 75 MG Oral CapsulePSNbf710bcf-75ed-4184-b9c3-81cd05a780a411
483438pregabalin 100 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483440pregabalin 150 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483446pregabalin 200 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
577127pregabalin 225 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483442pregabalin 25 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483444pregabalin 300 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483448pregabalin 50 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483450pregabalin 75 MG Oral CapsuleSCDbf710bcf-75ed-4184-b9c3-81cd05a780a411
483438pregabalin 100 MG Oral CapsulePSN3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483440pregabalin 150 MG Oral CapsulePSN3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483446pregabalin 200 MG Oral CapsulePSN3fdc6e94-2504-416c-81dd-2db9bc194ebb5
577127pregabalin 225 MG Oral CapsulePSN3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483442pregabalin 25 MG Oral CapsulePSN3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483444pregabalin 300 MG Oral CapsulePSN3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483448pregabalin 50 MG Oral CapsulePSN3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483450pregabalin 75 MG Oral CapsulePSN3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483438pregabalin 100 MG Oral CapsuleSCD3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483440pregabalin 150 MG Oral CapsuleSCD3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483446pregabalin 200 MG Oral CapsuleSCD3fdc6e94-2504-416c-81dd-2db9bc194ebb5
577127pregabalin 225 MG Oral CapsuleSCD3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483442pregabalin 25 MG Oral CapsuleSCD3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483444pregabalin 300 MG Oral CapsuleSCD3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483448pregabalin 50 MG Oral CapsuleSCD3fdc6e94-2504-416c-81dd-2db9bc194ebb5
483450pregabalin 75 MG Oral CapsuleSCD3fdc6e94-2504-416c-81dd-2db9bc194ebb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-568-0576282056805500 CAPSULE in 1 BOTTLE (76282-568-05) 500 capsule2019-07-190000-00-00NoNoCurrent
76282-568-907628205689090 CAPSULE in 1 BOTTLE (76282-568-90) 90 capsule2019-07-190000-00-00NoNoCurrent