Pregabalin

Product NDC
25000-180
11-digit product format
250000180
Labeler code
25000
Product ID
25000-180_b8d46cc7-2959-411f-839c-eced90c38e92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA216197
Marketing category
ANDA
Marketing start
2022-08-01
Substance
PREGABALIN
Active strength
50 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
A216197-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2022-07-18
A216197-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2022-07-18
A216197-003PREGABALINPREGABALIN75MGCAPSULE / ORALAB2022-07-18
A216197-004PREGABALINPREGABALIN100MGCAPSULE / ORALAB2022-07-18
A216197-005PREGABALINPREGABALIN150MGCAPSULE / ORALAB2022-07-18
A216197-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2022-07-18
A216197-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2022-07-18
A216197-008PREGABALINPREGABALIN300MGCAPSULE / ORALAB2022-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216197-001AB
A216197-002AB
A216197-003AB
A216197-004AB
A216197-005AB
A216197-006AB
A216197-007AB
A216197-008AB

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 6 · 216 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216197-001PREGABALIN25MGCAPSULE / ORALAB2022-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216197-002PREGABALIN50MGCAPSULE / ORALAB2022-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216197-003PREGABALIN75MGCAPSULE / ORALAB2022-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216197-004PREGABALIN100MGCAPSULE / ORALAB2022-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216197-005PREGABALIN150MGCAPSULE / ORALAB2022-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216197-006PREGABALIN200MGCAPSULE / ORALAB2022-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216197-007PREGABALIN225MGCAPSULE / ORALAB2022-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216197-008PREGABALIN300MGCAPSULE / ORALAB2022-07-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216197-001PREGABALIN25MGCAPSULE / ORALAB2022-07-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216197-002PREGABALIN50MGCAPSULE / ORALAB2022-07-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216197-003PREGABALIN75MGCAPSULE / ORALAB2022-07-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216197-004PREGABALIN100MGCAPSULE / ORALAB2022-07-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216197-005PREGABALIN150MGCAPSULE / ORALAB2022-07-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216197-006PREGABALIN200MGCAPSULE / ORALAB2022-07-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216197-007PREGABALIN225MGCAPSULE / ORALAB2022-07-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216197-008PREGABALIN300MGCAPSULE / ORALAB2022-07-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A216197-001PREGABALIN25MGCAPSULE / ORALAB2022-07-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216197-002PREGABALIN50MGCAPSULE / ORALAB2022-07-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216197-003PREGABALIN75MGCAPSULE / ORALAB2022-07-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216197-004PREGABALIN100MGCAPSULE / ORALAB2022-07-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216197-005PREGABALIN150MGCAPSULE / ORALAB2022-07-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216197-006PREGABALIN200MGCAPSULE / ORALAB2022-07-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216197-007PREGABALIN225MGCAPSULE / ORALAB2022-07-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216197-008PREGABALIN300MGCAPSULE / ORALAB2022-07-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216197-001PREGABALIN25MGCAPSULE / ORALAB2022-07-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216197-002PREGABALIN50MGCAPSULE / ORALAB2022-07-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216197-003PREGABALIN75MGCAPSULE / ORALAB2022-07-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216197-004PREGABALIN100MGCAPSULE / ORALAB2022-07-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216197-005PREGABALIN150MGCAPSULE / ORALAB2022-07-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216197-006PREGABALIN200MGCAPSULE / ORALAB2022-07-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216197-007PREGABALIN225MGCAPSULE / ORALAB2022-07-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216197-008PREGABALIN300MGCAPSULE / ORALAB2022-07-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216197-001PREGABALIN25MGCAPSULE / ORALAB2022-07-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216197-002PREGABALIN50MGCAPSULE / ORALAB2022-07-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216197-003PREGABALIN75MGCAPSULE / ORALAB2022-07-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216197-004PREGABALIN100MGCAPSULE / ORALAB2022-07-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216197-005PREGABALIN150MGCAPSULE / ORALAB2022-07-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216197-006PREGABALIN200MGCAPSULE / ORALAB2022-07-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216197-007PREGABALIN225MGCAPSULE / ORALAB2022-07-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216197-008PREGABALIN300MGCAPSULE / ORALAB2022-07-18b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 216 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216197-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216197-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216197-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216197-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216197-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216197-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216197-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216197-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216197-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216197-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216197-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216197-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216197-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216197-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216197-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216197-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216197-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216197-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216197-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216197-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216197-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216197-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216197-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216197-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216197-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216197-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216197-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216197-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216197-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216197-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216197-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216197-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216197-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216197-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216197-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216197-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216197-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216197-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216197-007AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216197-008AB1b8a1b40f171c…

Additional Listing Data#

Finished product
Yes
Brand name base
Pregabalin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN50 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
b2b81bb6-5423-4221-8a61-f70a38d6a1e9Available 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
25000-180-07Pregabalin90 in 1 BOTTLECAPSULE908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-180PREGABALIN CAPSULE [MARKSANS PHARMA LIMITED]7Current NDC, Legacy NDC, 1 package rows20240906_b2b81bb6-5423-4221-8a61-f70a38d6a1e9.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
PregabalinPREGABALINMARKSANS PHARMA LIMITEDb2b81bb6-5423-4221-8a61-f70a38d6a1e92025-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216197
application number: ANDA216197
ndc (product): 25000-180

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSNb2b81bb6-5423-4221-8a61-f70a38d6a1e98
483440pregabalin 150 MG Oral CapsulePSNb2b81bb6-5423-4221-8a61-f70a38d6a1e98
483446pregabalin 200 MG Oral CapsulePSNb2b81bb6-5423-4221-8a61-f70a38d6a1e98
577127pregabalin 225 MG Oral CapsulePSNb2b81bb6-5423-4221-8a61-f70a38d6a1e98
483442pregabalin 25 MG Oral CapsulePSNb2b81bb6-5423-4221-8a61-f70a38d6a1e98
483444pregabalin 300 MG Oral CapsulePSNb2b81bb6-5423-4221-8a61-f70a38d6a1e98
483448pregabalin 50 MG Oral CapsulePSNb2b81bb6-5423-4221-8a61-f70a38d6a1e98
483450pregabalin 75 MG Oral CapsulePSNb2b81bb6-5423-4221-8a61-f70a38d6a1e98
483438pregabalin 100 MG Oral CapsuleSCDb2b81bb6-5423-4221-8a61-f70a38d6a1e98
483440pregabalin 150 MG Oral CapsuleSCDb2b81bb6-5423-4221-8a61-f70a38d6a1e98
483446pregabalin 200 MG Oral CapsuleSCDb2b81bb6-5423-4221-8a61-f70a38d6a1e98
577127pregabalin 225 MG Oral CapsuleSCDb2b81bb6-5423-4221-8a61-f70a38d6a1e98
483442pregabalin 25 MG Oral CapsuleSCDb2b81bb6-5423-4221-8a61-f70a38d6a1e98
483444pregabalin 300 MG Oral CapsuleSCDb2b81bb6-5423-4221-8a61-f70a38d6a1e98
483448pregabalin 50 MG Oral CapsuleSCDb2b81bb6-5423-4221-8a61-f70a38d6a1e98
483450pregabalin 75 MG Oral CapsuleSCDb2b81bb6-5423-4221-8a61-f70a38d6a1e98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25000-180-072500001800790 CAPSULE in 1 BOTTLE (25000-180-07) 90 capsule2022-08-010000-00-00NoNoCurrent