Pregablin

Product NDC
33342-165
11-digit product format
333420165
Labeler code
33342
Product ID
33342-165_cb84edec-54d3-4100-99d9-b513cc6cbf1e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregablin
Dosage form
CAPSULE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA205924
Marketing category
ANDA
Marketing start
2024-11-13
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
A205924-001PREGABALINPREGABALIN25MGCAPSULE / ORAL2024-11-12
A205924-002PREGABALINPREGABALIN50MGCAPSULE / ORAL2024-11-12
A205924-003PREGABALINPREGABALIN75MGCAPSULE / ORAL2024-11-12
A205924-004PREGABALINPREGABALIN100MGCAPSULE / ORAL2024-11-12
A205924-005PREGABALINPREGABALIN150MGCAPSULE / ORAL2024-11-12
A205924-006PREGABALINPREGABALIN200MGCAPSULE / ORAL2024-11-12
A205924-007PREGABALINPREGABALIN225MGCAPSULE / ORAL2024-11-12
A205924-008PREGABALINPREGABALIN300MGCAPSULE / ORAL2024-11-12

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 2 · 64 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205924-001PREGABALIN25MGCAPSULE / ORAL2024-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205924-002PREGABALIN50MGCAPSULE / ORAL2024-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205924-003PREGABALIN75MGCAPSULE / ORAL2024-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205924-004PREGABALIN100MGCAPSULE / ORAL2024-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205924-005PREGABALIN150MGCAPSULE / ORAL2024-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205924-006PREGABALIN200MGCAPSULE / ORAL2024-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205924-007PREGABALIN225MGCAPSULE / ORAL2024-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205924-008PREGABALIN300MGCAPSULE / ORAL2024-11-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205924-001PREGABALIN25MGCAPSULE / ORAL2024-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205924-002PREGABALIN50MGCAPSULE / ORAL2024-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205924-003PREGABALIN75MGCAPSULE / ORAL2024-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205924-004PREGABALIN100MGCAPSULE / ORAL2024-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205924-005PREGABALIN150MGCAPSULE / ORAL2024-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205924-006PREGABALIN200MGCAPSULE / ORAL2024-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205924-007PREGABALIN225MGCAPSULE / ORAL2024-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205924-008PREGABALIN300MGCAPSULE / ORAL2024-11-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A205924-001PREGABALIN25MGCAPSULE / ORAL2024-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205924-002PREGABALIN50MGCAPSULE / ORAL2024-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205924-003PREGABALIN75MGCAPSULE / ORAL2024-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205924-004PREGABALIN100MGCAPSULE / ORAL2024-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205924-005PREGABALIN150MGCAPSULE / ORAL2024-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205924-006PREGABALIN200MGCAPSULE / ORAL2024-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205924-007PREGABALIN225MGCAPSULE / ORAL2024-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205924-008PREGABALIN300MGCAPSULE / ORAL2024-11-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205924-001PREGABALIN25MGCAPSULE / ORALAB2024-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205924-002PREGABALIN50MGCAPSULE / ORALAB2024-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205924-003PREGABALIN75MGCAPSULE / ORALAB2024-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205924-004PREGABALIN100MGCAPSULE / ORALAB2024-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205924-005PREGABALIN150MGCAPSULE / ORALAB2024-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205924-006PREGABALIN200MGCAPSULE / ORALAB2024-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205924-007PREGABALIN225MGCAPSULE / ORALAB2024-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205924-008PREGABALIN300MGCAPSULE / ORALAB2024-11-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205924-001PREGABALIN25MGCAPSULE / ORALAB2024-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205924-002PREGABALIN50MGCAPSULE / ORALAB2024-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205924-003PREGABALIN75MGCAPSULE / ORALAB2024-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205924-004PREGABALIN100MGCAPSULE / ORALAB2024-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205924-005PREGABALIN150MGCAPSULE / ORALAB2024-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205924-006PREGABALIN200MGCAPSULE / ORALAB2024-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205924-007PREGABALIN225MGCAPSULE / ORALAB2024-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205924-008PREGABALIN300MGCAPSULE / ORALAB2024-11-12b8a1b40f171c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205924-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205924-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205924-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205924-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205924-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205924-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205924-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205924-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205924-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205924-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205924-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205924-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205924-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205924-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205924-007AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205924-008AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205924-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205924-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205924-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205924-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205924-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205924-006AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205924-007AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205924-008AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205924-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205924-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205924-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205924-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205924-005AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205924-006AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205924-007AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205924-008AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Pregablin
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
a3a94949-3060-4057-9b29-e06a808cbd76Available 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
33342-165-10Pregablin90 in 1 BOTTLECAPSULE902

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
PregablinPREGABLINMacleods Pharmaceuticals Limiteda3a94949-3060-4057-9b29-e06a808cbd762025-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205924
application number: ANDA205924
ndc (product): 33342-165

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSNa3a94949-3060-4057-9b29-e06a808cbd762
483440pregabalin 150 MG Oral CapsulePSNa3a94949-3060-4057-9b29-e06a808cbd762
483446pregabalin 200 MG Oral CapsulePSNa3a94949-3060-4057-9b29-e06a808cbd762
577127pregabalin 225 MG Oral CapsulePSNa3a94949-3060-4057-9b29-e06a808cbd762
483442pregabalin 25 MG Oral CapsulePSNa3a94949-3060-4057-9b29-e06a808cbd762
483444pregabalin 300 MG Oral CapsulePSNa3a94949-3060-4057-9b29-e06a808cbd762
483448pregabalin 50 MG Oral CapsulePSNa3a94949-3060-4057-9b29-e06a808cbd762
483450pregabalin 75 MG Oral CapsulePSNa3a94949-3060-4057-9b29-e06a808cbd762
483438pregabalin 100 MG Oral CapsuleSCDa3a94949-3060-4057-9b29-e06a808cbd762
483440pregabalin 150 MG Oral CapsuleSCDa3a94949-3060-4057-9b29-e06a808cbd762
483446pregabalin 200 MG Oral CapsuleSCDa3a94949-3060-4057-9b29-e06a808cbd762
577127pregabalin 225 MG Oral CapsuleSCDa3a94949-3060-4057-9b29-e06a808cbd762
483442pregabalin 25 MG Oral CapsuleSCDa3a94949-3060-4057-9b29-e06a808cbd762
483444pregabalin 300 MG Oral CapsuleSCDa3a94949-3060-4057-9b29-e06a808cbd762
483448pregabalin 50 MG Oral CapsuleSCDa3a94949-3060-4057-9b29-e06a808cbd762
483450pregabalin 75 MG Oral CapsuleSCDa3a94949-3060-4057-9b29-e06a808cbd762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-165-103334201651090 CAPSULE in 1 BOTTLE (33342-165-10) 90 capsule2024-11-13NoNoCurrent