Pregabalin

Product NDC
72603-356
Requested package NDC
72603-356-01
11-digit product format
726030356
Labeler code
72603
Product ID
72603-356_45bca2c9-2de2-8684-e063-6294a90a1bdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA206912
Marketing category
ANDA
Marketing start
2025-12-15
Substance
PREGABALIN
Active strength
150 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
A206912-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2019-10-08
A206912-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2019-10-08
A206912-003PREGABALINPREGABALIN75MGCAPSULE / ORALAB2019-10-08
A206912-004PREGABALINPREGABALIN100MGCAPSULE / ORALAB2019-10-08
A206912-005PREGABALINPREGABALIN150MGCAPSULE / ORALAB2019-10-08
A206912-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2019-10-08
A206912-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2019-10-08
A206912-008PREGABALINPREGABALIN300MGCAPSULE / ORALAB2019-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206912-001AB
A206912-002AB
A206912-003AB
A206912-004AB
A206912-005AB
A206912-006AB
A206912-007AB
A206912-008AB

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 · 328 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206912-001PREGABALIN25MGCAPSULE / ORALAB2019-10-0884e616aacf4f…
2026-09-14 22:38:342026-08A206912-002PREGABALIN50MGCAPSULE / ORALAB2019-10-0884e616aacf4f…
2026-09-14 22:38:342026-08A206912-003PREGABALIN75MGCAPSULE / ORALAB2019-10-0884e616aacf4f…
2026-09-14 22:38:342026-08A206912-004PREGABALIN100MGCAPSULE / ORALAB2019-10-0884e616aacf4f…
2026-09-14 22:38:342026-08A206912-005PREGABALIN150MGCAPSULE / ORALAB2019-10-0884e616aacf4f…
2026-09-14 22:38:342026-08A206912-006PREGABALIN200MGCAPSULE / ORALAB2019-10-0884e616aacf4f…
2026-09-14 22:38:342026-08A206912-007PREGABALIN225MGCAPSULE / ORALAB2019-10-0884e616aacf4f…
2026-09-14 22:38:342026-08A206912-008PREGABALIN300MGCAPSULE / ORALAB2019-10-0884e616aacf4f…
2026-08-18 06:07:402026-07A206912-001PREGABALIN25MGCAPSULE / ORALAB2019-10-08caaa826d4ba7…
2026-08-18 06:07:402026-07A206912-002PREGABALIN50MGCAPSULE / ORALAB2019-10-08caaa826d4ba7…
2026-08-18 06:07:402026-07A206912-003PREGABALIN75MGCAPSULE / ORALAB2019-10-08caaa826d4ba7…
2026-08-18 06:07:402026-07A206912-004PREGABALIN100MGCAPSULE / ORALAB2019-10-08caaa826d4ba7…
2026-08-18 06:07:402026-07A206912-005PREGABALIN150MGCAPSULE / ORALAB2019-10-08caaa826d4ba7…
2026-08-18 06:07:402026-07A206912-006PREGABALIN200MGCAPSULE / ORALAB2019-10-08caaa826d4ba7…
2026-08-18 06:07:402026-07A206912-007PREGABALIN225MGCAPSULE / ORALAB2019-10-08caaa826d4ba7…
2026-08-18 06:07:402026-07A206912-008PREGABALIN300MGCAPSULE / ORALAB2019-10-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206912-001PREGABALIN25MGCAPSULE / ORALAB2019-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-002PREGABALIN50MGCAPSULE / ORALAB2019-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-003PREGABALIN75MGCAPSULE / ORALAB2019-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-004PREGABALIN100MGCAPSULE / ORALAB2019-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-005PREGABALIN150MGCAPSULE / ORALAB2019-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-006PREGABALIN200MGCAPSULE / ORALAB2019-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-007PREGABALIN225MGCAPSULE / ORALAB2019-10-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-008PREGABALIN300MGCAPSULE / ORALAB2019-10-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-001PREGABALIN25MGCAPSULE / ORALAB2019-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-002PREGABALIN50MGCAPSULE / ORALAB2019-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-003PREGABALIN75MGCAPSULE / ORALAB2019-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-004PREGABALIN100MGCAPSULE / ORALAB2019-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-005PREGABALIN150MGCAPSULE / ORALAB2019-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-006PREGABALIN200MGCAPSULE / ORALAB2019-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-007PREGABALIN225MGCAPSULE / ORALAB2019-10-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-008PREGABALIN300MGCAPSULE / ORALAB2019-10-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A206912-001PREGABALIN25MGCAPSULE / ORALAB2019-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-002PREGABALIN50MGCAPSULE / ORALAB2019-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-003PREGABALIN75MGCAPSULE / ORALAB2019-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-004PREGABALIN100MGCAPSULE / ORALAB2019-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-005PREGABALIN150MGCAPSULE / ORALAB2019-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-006PREGABALIN200MGCAPSULE / ORALAB2019-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-007PREGABALIN225MGCAPSULE / ORALAB2019-10-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-008PREGABALIN300MGCAPSULE / ORALAB2019-10-086a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 328 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A206912-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A206912-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A206912-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A206912-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A206912-005AB184e616aacf4f…
2026-09-14 22:38:342026-08A206912-006AB184e616aacf4f…
2026-09-14 22:38:342026-08A206912-007AB184e616aacf4f…
2026-09-14 22:38:342026-08A206912-008AB184e616aacf4f…
2026-08-18 06:07:402026-07A206912-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206912-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206912-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206912-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206912-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206912-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206912-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206912-008AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206912-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206912-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206912-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206912-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206912-008AB16a471c1ec25d…

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
PREGABALIN150 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 · 7 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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4a4d4c76-31c5-413b-be7c-82cb8091c19dAvailable 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-356-01Pregabalin90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-356-01EA - Each72603-35609f43f97-6dcd-4a9e-99b3-9a2f77b9f81012026-03-17

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINREMEDYREPACK INC.e897d7e8-2743-4512-8417-375cb11ceec62026-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINREMEDYREPACK INC.84bf3abb-559d-4140-a689-f3e26b1c4ff22026-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINPreferred Pharmaceuticals Inc.7f29991e-3bf5-4e48-8fa3-6d4e932ed6de2026-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINREMEDYREPACK INC.5d738807-7f88-4943-9c3b-01f1e52ea72d2026-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINREMEDYREPACK INC.9685792b-911d-4cf9-9881-d21abca48c662026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINREMEDYREPACK INC.c60752f8-20d5-4333-bf33-a656eab01d6b2026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINREMEDYREPACK INC.0f72ec70-314c-4c9f-86be-54f3e010356d2026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINBryant Ranch Prepack1e6fa742-f658-495f-88bb-8eddf9a45ffe2026-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINBryant Ranch Prepack48798c13-3ef4-4e7f-9f73-92dccac0af142026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy2c62e63a-fe81-a463-e063-6394a90a65ee2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINA-S Medication Solutionsb740832a-6e90-4b20-bfed-be0415f1aebe2026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINProficient Rx LPefc36145-fffd-44de-9a42-f277d0ff39c92026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINNorthStar RxLLC4a4d4c76-31c5-413b-be7c-82cb8091c19d2025-12-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
ndc (package): 72603-356-01
ndc (product): 72603-356
ndc11 (package): 72603035601
PregabalinPREGABALINCamber Pharmaceuticals, Inc.241c4b7e-f719-4828-8639-ea613b8a65832025-09-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINPreferred Pharmaceuticals Inc.dc50f01d-1802-4666-8f2f-35980a40990f2025-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINProficient Rx LPa025e4fc-e0c1-4c5b-a1c8-bd8e578a737e2025-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINProficient Rx LP2b87989d-6411-4996-8f05-05806ab805252025-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCd28168cd-9b7a-f8df-e053-2995a90ad97f2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCc6b456ca-9d07-7789-e053-2a95a90a20c52024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCc8bfc4f9-6208-4eaa-e053-2a95a90ada972024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206912
application number: ANDA206912

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN4a4d4c76-31c5-413b-be7c-82cb8091c19d1
483440pregabalin 150 MG Oral CapsulePSN4a4d4c76-31c5-413b-be7c-82cb8091c19d1
483446pregabalin 200 MG Oral CapsulePSN4a4d4c76-31c5-413b-be7c-82cb8091c19d1
483442pregabalin 25 MG Oral CapsulePSN4a4d4c76-31c5-413b-be7c-82cb8091c19d1
483444pregabalin 300 MG Oral CapsulePSN4a4d4c76-31c5-413b-be7c-82cb8091c19d1
483448pregabalin 50 MG Oral CapsulePSN4a4d4c76-31c5-413b-be7c-82cb8091c19d1
483450pregabalin 75 MG Oral CapsulePSN4a4d4c76-31c5-413b-be7c-82cb8091c19d1
483438pregabalin 100 MG Oral CapsuleSCD4a4d4c76-31c5-413b-be7c-82cb8091c19d1
483440pregabalin 150 MG Oral CapsuleSCD4a4d4c76-31c5-413b-be7c-82cb8091c19d1
483446pregabalin 200 MG Oral CapsuleSCD4a4d4c76-31c5-413b-be7c-82cb8091c19d1
483442pregabalin 25 MG Oral CapsuleSCD4a4d4c76-31c5-413b-be7c-82cb8091c19d1
483444pregabalin 300 MG Oral CapsuleSCD4a4d4c76-31c5-413b-be7c-82cb8091c19d1
483448pregabalin 50 MG Oral CapsuleSCD4a4d4c76-31c5-413b-be7c-82cb8091c19d1
483450pregabalin 75 MG Oral CapsuleSCD4a4d4c76-31c5-413b-be7c-82cb8091c19d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-356-017260303560190 CAPSULE in 1 BOTTLE (72603-356-01) 90 capsule2025-12-15NoNoCurrent