Pregabalin

Product NDC
46708-119
11-digit product format
467080119
Labeler code
46708
Product ID
46708-119_b746d2ae-57e4-4a36-9524-35c4aa6b4ef2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA203459
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 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
A203459-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2019-07-19
A203459-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2019-07-19
A203459-003PREGABALINPREGABALIN75MGCAPSULE / ORALAB2019-07-19
A203459-004PREGABALINPREGABALIN100MGCAPSULE / ORALAB2019-07-19
A203459-005PREGABALINPREGABALIN150MGCAPSULE / ORALAB2019-07-19
A203459-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2019-07-19
A203459-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2019-07-19
A203459-008PREGABALINPREGABALIN300MGCAPSULE / 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
A203459-001AB
A203459-002AB
A203459-003AB
A203459-004AB
A203459-005AB
A203459-006AB
A203459-007AB
A203459-008AB

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 · 320 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203459-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203459-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203459-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203459-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203459-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203459-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203459-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203459-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203459-001PREGABALIN25MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203459-002PREGABALIN50MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203459-003PREGABALIN75MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203459-004PREGABALIN100MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203459-005PREGABALIN150MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203459-006PREGABALIN200MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203459-007PREGABALIN225MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203459-008PREGABALIN300MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203459-001PREGABALIN25MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203459-002PREGABALIN50MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203459-003PREGABALIN75MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203459-004PREGABALIN100MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203459-005PREGABALIN150MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203459-006PREGABALIN200MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203459-007PREGABALIN225MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203459-008PREGABALIN300MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203459-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203459-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203459-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203459-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203459-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203459-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203459-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203459-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203459-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203459-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203459-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203459-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203459-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203459-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203459-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203459-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 320 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203459-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203459-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203459-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203459-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203459-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203459-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203459-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203459-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203459-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203459-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203459-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203459-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203459-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203459-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203459-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203459-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203459-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203459-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203459-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203459-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203459-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203459-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203459-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203459-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203459-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203459-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203459-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203459-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203459-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203459-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203459-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203459-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203459-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203459-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203459-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203459-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203459-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203459-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203459-007AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203459-008AB1b8a1b40f171c…

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
78a36538-701d-4dd9-a7fc-87d505784c83Available 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
46708-119-10Pregabalin100 in 1 CARTONCAPSULE1004
46708-119-30Pregabalin30 in 1 BOTTLECAPSULE304
46708-119-90Pregabalin90 in 1 BOTTLECAPSULE904
46708-119-91Pregabalin1000 in 1 BOTTLECAPSULE10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-119PREGABALIN CAPSULE [ALEMBIC PHARMACEUTICALS LIMITED]4Current NDC, Legacy NDC, 4 package rows20230513_78a36538-701d-4dd9-a7fc-87d505784c83.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINAlembic Pharmaceuticals Inc.cf7b4b67-b017-47ac-af3f-bde5bd07bb0c2025-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203459
application number: ANDA203459
PregabalinPREGABALINAlembic Pharmaceuticals Limited78a36538-701d-4dd9-a7fc-87d505784c832023-05-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203459
application number: ANDA203459
ndc (product): 46708-119

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN78a36538-701d-4dd9-a7fc-87d505784c834
483440pregabalin 150 MG Oral CapsulePSN78a36538-701d-4dd9-a7fc-87d505784c834
483446pregabalin 200 MG Oral CapsulePSN78a36538-701d-4dd9-a7fc-87d505784c834
577127pregabalin 225 MG Oral CapsulePSN78a36538-701d-4dd9-a7fc-87d505784c834
483442pregabalin 25 MG Oral CapsulePSN78a36538-701d-4dd9-a7fc-87d505784c834
483444pregabalin 300 MG Oral CapsulePSN78a36538-701d-4dd9-a7fc-87d505784c834
483448pregabalin 50 MG Oral CapsulePSN78a36538-701d-4dd9-a7fc-87d505784c834
483450pregabalin 75 MG Oral CapsulePSN78a36538-701d-4dd9-a7fc-87d505784c834
483438pregabalin 100 MG Oral CapsuleSCD78a36538-701d-4dd9-a7fc-87d505784c834
483440pregabalin 150 MG Oral CapsuleSCD78a36538-701d-4dd9-a7fc-87d505784c834
483446pregabalin 200 MG Oral CapsuleSCD78a36538-701d-4dd9-a7fc-87d505784c834
577127pregabalin 225 MG Oral CapsuleSCD78a36538-701d-4dd9-a7fc-87d505784c834
483442pregabalin 25 MG Oral CapsuleSCD78a36538-701d-4dd9-a7fc-87d505784c834
483444pregabalin 300 MG Oral CapsuleSCD78a36538-701d-4dd9-a7fc-87d505784c834
483448pregabalin 50 MG Oral CapsuleSCD78a36538-701d-4dd9-a7fc-87d505784c834
483450pregabalin 75 MG Oral CapsuleSCD78a36538-701d-4dd9-a7fc-87d505784c834

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-119-1046708011910100 CAPSULE in 1 CARTON (46708-119-10) 100 capsule2019-07-190000-00-00NoNoCurrent
46708-119-304670801193030 CAPSULE in 1 BOTTLE (46708-119-30) 30 capsule2019-07-190000-00-00NoNoCurrent
46708-119-904670801199090 CAPSULE in 1 BOTTLE (46708-119-90) 90 capsule2019-07-190000-00-00NoNoCurrent
46708-119-91467080119911000 CAPSULE in 1 BOTTLE (46708-119-91) 1000 capsule2019-07-190000-00-00NoNoCurrent