PREGABALIN

Product NDC
72189-033
Requested package NDC
72189-033-30
11-digit product format
721890033
Labeler code
72189
Product ID
72189-033_2be8eb66-533f-0815-e063-6294a90a115d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA209743
Marketing category
ANDA
Marketing start
2019-09-05
Substance
PREGABALIN
Active strength
100 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-03372189-033-30UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A209743-001PREGABALINPREGABALIN25MGCAPSULE / ORALAB2019-07-19
A209743-002PREGABALINPREGABALIN50MGCAPSULE / ORALAB2019-07-19
A209743-003PREGABALINPREGABALIN75MGCAPSULE / ORALAB2019-07-19
A209743-004PREGABALINPREGABALIN100MGCAPSULE / ORALAB2019-07-19
A209743-005PREGABALINPREGABALIN150MGCAPSULE / ORALAB2019-07-19
A209743-006PREGABALINPREGABALIN200MGCAPSULE / ORALAB2019-07-19
A209743-007PREGABALINPREGABALIN225MGCAPSULE / ORALAB2019-07-19
A209743-008PREGABALINPREGABALIN300MGCAPSULE / 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
A209743-001AB
A209743-002AB
A209743-003AB
A209743-004AB
A209743-005AB
A209743-006AB
A209743-007AB
A209743-008AB

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
2026-08-18 06:07:402026-07A209743-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209743-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-001PREGABALIN25MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-002PREGABALIN50MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-003PREGABALIN75MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-004PREGABALIN100MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-005PREGABALIN150MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-006PREGABALIN200MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-007PREGABALIN225MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-008PREGABALIN300MGCAPSULE / ORALAB2019-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A209743-001PREGABALIN25MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-002PREGABALIN50MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-003PREGABALIN75MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-004PREGABALIN100MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-005PREGABALIN150MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-006PREGABALIN200MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-007PREGABALIN225MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-008PREGABALIN300MGCAPSULE / ORALAB2019-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-001PREGABALIN25MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-002PREGABALIN50MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-003PREGABALIN75MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-004PREGABALIN100MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-005PREGABALIN150MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-006PREGABALIN200MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-007PREGABALIN225MGCAPSULE / ORALAB2019-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-008PREGABALIN300MGCAPSULE / ORALAB2019-07-19fd3edfee7708…

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
2026-08-18 06:07:402026-07A209743-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-006AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-007AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209743-008AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209743-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209743-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209743-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209743-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209743-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209743-008AB1fd3edfee7708…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN100 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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
483438Internal RxNorm lookup
483442Internal RxNorm lookup
483444Internal RxNorm lookup
483446Internal 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
91cf12b1-e1a6-dbc2-e053-2a95a90a8d5dAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72189-033-602023-01-30C16284748780-1f386c649-d49f-0266-e053-dadaa90a7c1aPREGABALIN
72189-033-902023-01-30C16284748780-1f386c64a-3c7a-0266-e053-dadaa90a7c1aPREGABALIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-033-30PREGABALIN30 in 1 BOTTLECAPSULE3013
72189-033-60PREGABALIN60 in 1 BOTTLECAPSULE601
72189-033-90PREGABALIN90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-033-30EA - Each72189-03355e846f9-ec65-47ef-9a20-24269c6a546a12019-10-07
72189-033-60EA - Each72189-03347301aa4-77fb-44be-8774-e2e91a3fa80312019-10-07
72189-033-90EA - Each72189-0336902c501-94a1-4f0c-8c80-739e4278230a12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-033PREGABALIN CAPSULE [DIRECT_RX]13Current NDC, Legacy NDC, 1 package rows20250119_91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d.zip
72189-033PREGABALIN CAPSULE [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190906_91cf34b3-d546-3110-e053-2995a90a5788.zip
72189-033PREGABALIN CAPSULE [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190906_91cf4a51-18aa-06a6-e053-2995a90a93bd.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINREMEDYREPACK INC.d095accf-9cea-4948-b43d-ae1b8fbce7c22026-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAmneal Pharmaceuticals NY LLC3d9d7123-5886-4b61-a7ea-471b213e77d92026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAmneal Pharmaceuticals NY LLC3099759f-cb24-40e8-b482-9388c38c73b92025-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PREGABALINPREGABALINDirect_Rx91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d2025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
ndc (package): 72189-033-30
ndc (product): 72189-033
ndc11 (package): 72189003330
PregabalinPREGABALINAdvanced Rx of Tennessee, LLCafc89ca3-5597-1c75-e053-2a95a90a3ff22024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAdvanced Rx of Tennessee, LLCaf739a0d-a3cd-754f-e053-2a95a90ad6552024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCb8172d6b-a646-e559-e053-2a95a90ac24d2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCbc1b143d-feaf-9498-e053-2995a90acf502024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCb817083c-b535-2269-e053-2a95a90af5b92024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743
PregabalinPREGABALINProficient Rx LPa17f03ea-9375-48fe-be32-f8df509f5fba2023-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209743
application number: ANDA209743

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483438pregabalin 100 MG Oral CapsulePSN91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483446pregabalin 200 MG Oral CapsulePSN91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
577127pregabalin 225 MG Oral CapsulePSN91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483442pregabalin 25 MG Oral CapsulePSN91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483444pregabalin 300 MG Oral CapsulePSN91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483438pregabalin 100 MG Oral CapsuleSCD91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483446pregabalin 200 MG Oral CapsuleSCD91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
577127pregabalin 225 MG Oral CapsuleSCD91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483442pregabalin 25 MG Oral CapsuleSCD91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483444pregabalin 300 MG Oral CapsuleSCD91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d13
483438pregabalin 100 MG Oral CapsulePSN91cf34b3-d546-3110-e053-2995a90a57881
483438pregabalin 100 MG Oral CapsulePSN91cf4a51-18aa-06a6-e053-2995a90a93bd1
483438pregabalin 100 MG Oral CapsuleSCD91cf34b3-d546-3110-e053-2995a90a57881
483438pregabalin 100 MG Oral CapsuleSCD91cf4a51-18aa-06a6-e053-2995a90a93bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-033-307218900333030 CAPSULE in 1 BOTTLE (72189-033-30) 30 capsule2019-09-050000-00-00NoNoCurrent