PREGABALIN

Product NDC
72189-028
Requested package NDC
72189-028-90
11-digit product format
721890028
Labeler code
72189
Product ID
72189-028_91421052-0987-d146-e053-2a95a90ad106
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA209743
Marketing category
ANDA
Marketing start
2019-08-29
Marketing end
0000-00-00
Substance
PREGABALIN
Active strength
50 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72189-02872189-028-90IInactivated by FDA2026-09-09

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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…

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
72189-028-302023-01-30C16284748780-1f386c64a-2291-0266-e053-dadaa90a7c1aPREGABALIN
72189-028-602023-01-30C16284748780-1f386c64a-11b6-0266-e053-dadaa90a7c1aPREGABALIN
72189-028-902023-01-30C16284748780-1f386c649-ffc3-0266-e053-dadaa90a7c1aPREGABALIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-028-30PREGABALIN30 in 1 BOTTLECAPSULE301
72189-028-60PREGABALIN60 in 1 BOTTLECAPSULE601
72189-028-90PREGABALIN90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-028-30EA - Each72189-0280684607c-690d-478f-9395-40a5acd368e312019-09-05
72189-028-60EA - Each72189-02832757f55-ba3d-46fd-90e2-9a8da8cf457c12019-09-05
72189-028-90EA - Each72189-028effef1db-eadf-49e7-85a7-6e8bea86fb4012019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-028PREGABALIN CAPSULE [DIRECT_RX]1Legacy NDC, 1 package rows20190830_9142c0c5-3e4a-4728-e053-2a95a90a0ba1.zip
72189-028PREGABALIN CAPSULE [DIRECT_RX]1Legacy NDC, 1 package rows20190830_91427e4b-530c-f53d-e053-2a95a90a1e6e.zip
72189-028PREGABALIN CAPSULE [DIRECT_RX]1Legacy NDC, 1 package rows20190830_91421052-0986-d146-e053-2a95a90ad106.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
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
483448pregabalin 50 MG Oral CapsulePSN91421052-0986-d146-e053-2a95a90ad1061
483448pregabalin 50 MG Oral CapsulePSN91427e4b-530c-f53d-e053-2a95a90a1e6e1
483448pregabalin 50 MG Oral CapsulePSN9142c0c5-3e4a-4728-e053-2a95a90a0ba11
483448pregabalin 50 MG Oral CapsuleSCD91421052-0986-d146-e053-2a95a90ad1061
483448pregabalin 50 MG Oral CapsuleSCD91427e4b-530c-f53d-e053-2a95a90a1e6e1
483448pregabalin 50 MG Oral CapsuleSCD9142c0c5-3e4a-4728-e053-2a95a90a0ba11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-028-907218900289090 CAPSULE in 1 BOTTLE (72189-028-90) 90 capsule2019-08-290000-00-00NoNoCurrent