Home NDC 0228-2862 Pregabalin
Product NDC 0228-2862
11-digit product format 002282862
Labeler code 0228
Product ID 0228-2862_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 225 mg/1
DEA schedule CV
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0228-2862-09 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0228-2862-09 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0228-2862-09 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0228-2862-09 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0228-2862-09 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0228-2862-09 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0228-2862-09 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0228-2862-09 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0228-2862-09 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0228-2862-09 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0228-2862-09 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0228-2862-09 557ba5c1ecfa…9c80585c8c6e…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091025-001 PREGABALIN PREGABALIN 25MG CAPSULE / ORAL 2020-07-09 A091025-002 PREGABALIN PREGABALIN 50MG CAPSULE / ORAL 2020-07-09 A091025-003 PREGABALIN PREGABALIN 75MG CAPSULE / ORAL 2020-07-09 A091025-004 PREGABALIN PREGABALIN 100MG CAPSULE / ORAL 2020-07-09 A091025-005 PREGABALIN PREGABALIN 150MG CAPSULE / ORAL 2020-07-09 A091025-006 PREGABALIN PREGABALIN 200MG CAPSULE / ORAL 2020-07-09 A091025-007 PREGABALIN PREGABALIN 225MG CAPSULE / ORAL 2020-07-09 A091025-008 PREGABALIN PREGABALIN 300MG CAPSULE / ORAL 2020-07-09
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A091025-001 PREGABALIN 25MG CAPSULE / ORAL 2020-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091025-002 PREGABALIN 50MG CAPSULE / ORAL 2020-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091025-003 PREGABALIN 75MG CAPSULE / ORAL 2020-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091025-004 PREGABALIN 100MG CAPSULE / ORAL 2020-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091025-005 PREGABALIN 150MG CAPSULE / ORAL 2020-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091025-006 PREGABALIN 200MG CAPSULE / ORAL 2020-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091025-007 PREGABALIN 225MG CAPSULE / ORAL 2020-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091025-008 PREGABALIN 300MG CAPSULE / ORAL 2020-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091025-001 PREGABALIN 25MG CAPSULE / ORAL 2020-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091025-002 PREGABALIN 50MG CAPSULE / ORAL 2020-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091025-003 PREGABALIN 75MG CAPSULE / ORAL 2020-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091025-004 PREGABALIN 100MG CAPSULE / ORAL 2020-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091025-005 PREGABALIN 150MG CAPSULE / ORAL 2020-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091025-006 PREGABALIN 200MG CAPSULE / ORAL 2020-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091025-007 PREGABALIN 225MG CAPSULE / ORAL 2020-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091025-008 PREGABALIN 300MG CAPSULE / ORAL 2020-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091025-001 PREGABALIN 25MG CAPSULE / ORAL 2020-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091025-002 PREGABALIN 50MG CAPSULE / ORAL 2020-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091025-003 PREGABALIN 75MG CAPSULE / ORAL 2020-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091025-004 PREGABALIN 100MG CAPSULE / ORAL 2020-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091025-005 PREGABALIN 150MG CAPSULE / ORAL 2020-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091025-006 PREGABALIN 200MG CAPSULE / ORAL 2020-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091025-007 PREGABALIN 225MG CAPSULE / ORAL 2020-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091025-008 PREGABALIN 300MG CAPSULE / ORAL 2020-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091025-001 PREGABALIN 25MG CAPSULE / ORAL AB 2020-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091025-002 PREGABALIN 50MG CAPSULE / ORAL AB 2020-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091025-003 PREGABALIN 75MG CAPSULE / ORAL AB 2020-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091025-004 PREGABALIN 100MG CAPSULE / ORAL AB 2020-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091025-005 PREGABALIN 150MG CAPSULE / ORAL AB 2020-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091025-006 PREGABALIN 200MG CAPSULE / ORAL AB 2020-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091025-007 PREGABALIN 225MG CAPSULE / ORAL AB 2020-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091025-008 PREGABALIN 300MG CAPSULE / ORAL AB 2020-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091025-001 PREGABALIN 25MG CAPSULE / ORAL AB 2020-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091025-002 PREGABALIN 50MG CAPSULE / ORAL AB 2020-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091025-003 PREGABALIN 75MG CAPSULE / ORAL AB 2020-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091025-004 PREGABALIN 100MG CAPSULE / ORAL AB 2020-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091025-005 PREGABALIN 150MG CAPSULE / ORAL AB 2020-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091025-006 PREGABALIN 200MG CAPSULE / ORAL AB 2020-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091025-007 PREGABALIN 225MG CAPSULE / ORAL AB 2020-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091025-008 PREGABALIN 300MG CAPSULE / ORAL AB 2020-07-09 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 264 observed states.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0228-2862-09 00228286209 90 CAPSULE in 1 BOTTLE (0228-2862-09) 90 capsule 2020-10-08 0000-00-00 No No Current