Pregabalin

Product NDC
0228-2863
11-digit product format
002282863
Labeler code
0228
Product ID
0228-2863_d5bb20c2-0ad7-4245-a706-4222a5fdf57b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pregabalin
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA091025
Marketing category
ANDA
Marketing start
2020-10-08
Marketing end
0000-00-00
Substance
PREGABALIN
Active strength
300 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0228-2863DDiscontinued by firm2026-08-03
excluded packagepackage0228-28630228-2863-09DDiscontinued by firm2026-08-03

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0228-2863-09d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0228-2863-09f5e01cc5f278…a2eaf40c39c3…

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
A091025-001PREGABALINPREGABALIN25MGCAPSULE / ORAL2020-07-09
A091025-002PREGABALINPREGABALIN50MGCAPSULE / ORAL2020-07-09
A091025-003PREGABALINPREGABALIN75MGCAPSULE / ORAL2020-07-09
A091025-004PREGABALINPREGABALIN100MGCAPSULE / ORAL2020-07-09
A091025-005PREGABALINPREGABALIN150MGCAPSULE / ORAL2020-07-09
A091025-006PREGABALINPREGABALIN200MGCAPSULE / ORAL2020-07-09
A091025-007PREGABALINPREGABALIN225MGCAPSULE / ORAL2020-07-09
A091025-008PREGABALINPREGABALIN300MGCAPSULE / ORAL2020-07-09

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 · 296 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091025-001PREGABALIN25MGCAPSULE / ORAL2020-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091025-002PREGABALIN50MGCAPSULE / ORAL2020-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091025-003PREGABALIN75MGCAPSULE / ORAL2020-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091025-004PREGABALIN100MGCAPSULE / ORAL2020-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091025-005PREGABALIN150MGCAPSULE / ORAL2020-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091025-006PREGABALIN200MGCAPSULE / ORAL2020-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091025-007PREGABALIN225MGCAPSULE / ORAL2020-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091025-008PREGABALIN300MGCAPSULE / ORAL2020-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091025-001PREGABALIN25MGCAPSULE / ORAL2020-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091025-002PREGABALIN50MGCAPSULE / ORAL2020-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091025-003PREGABALIN75MGCAPSULE / ORAL2020-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091025-004PREGABALIN100MGCAPSULE / ORAL2020-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091025-005PREGABALIN150MGCAPSULE / ORAL2020-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091025-006PREGABALIN200MGCAPSULE / ORAL2020-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091025-007PREGABALIN225MGCAPSULE / ORAL2020-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091025-008PREGABALIN300MGCAPSULE / ORAL2020-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A091025-001PREGABALIN25MGCAPSULE / ORAL2020-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091025-002PREGABALIN50MGCAPSULE / ORAL2020-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091025-003PREGABALIN75MGCAPSULE / ORAL2020-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091025-004PREGABALIN100MGCAPSULE / ORAL2020-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091025-005PREGABALIN150MGCAPSULE / ORAL2020-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091025-006PREGABALIN200MGCAPSULE / ORAL2020-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091025-007PREGABALIN225MGCAPSULE / ORAL2020-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091025-008PREGABALIN300MGCAPSULE / ORAL2020-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-001PREGABALIN25MGCAPSULE / ORALAB2020-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-002PREGABALIN50MGCAPSULE / ORALAB2020-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-003PREGABALIN75MGCAPSULE / ORALAB2020-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-004PREGABALIN100MGCAPSULE / ORALAB2020-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-005PREGABALIN150MGCAPSULE / ORALAB2020-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-006PREGABALIN200MGCAPSULE / ORALAB2020-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-007PREGABALIN225MGCAPSULE / ORALAB2020-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-008PREGABALIN300MGCAPSULE / ORALAB2020-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-001PREGABALIN25MGCAPSULE / ORALAB2020-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-002PREGABALIN50MGCAPSULE / ORALAB2020-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-003PREGABALIN75MGCAPSULE / ORALAB2020-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-004PREGABALIN100MGCAPSULE / ORALAB2020-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-005PREGABALIN150MGCAPSULE / ORALAB2020-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-006PREGABALIN200MGCAPSULE / ORALAB2020-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-007PREGABALIN225MGCAPSULE / ORALAB2020-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-008PREGABALIN300MGCAPSULE / ORALAB2020-07-09b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091025-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-007AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091025-008AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091025-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091025-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091025-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091025-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091025-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091025-006AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091025-007AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091025-008AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091025-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091025-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091025-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091025-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091025-005AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091025-006AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091025-007AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091025-008AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091025-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091025-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091025-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091025-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091025-005AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091025-006AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091025-007AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091025-008AB15bbf6a4d5a75…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0228-2863-090022828630990 CAPSULE in 1 BOTTLE (0228-2863-09) 90 capsule2020-10-080000-00-00NoNoCurrent