Home NDC 50090-4465 Pregabalin
Product NDC 50090-4465
11-digit product format 500904465
Labeler code 50090
Product ID 50090-4465_f900fe69-1b6f-4bc6-9f62-978eab36a41e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pregabalin
Dosage form CAPSULE
Route ORAL
Labeler A-S Medication Solutions
Application ANDA203459
Marketing category ANDA
Marketing start 2019-07-19
Marketing end 0000-00-00
Substance PREGABALIN
Active strength 75 mg/1
DEA schedule CV
NDC exclude flag No
Listing certified through 2020-12-31
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 50090-4465-0 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 50090-4465-0 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 50090-4465-0 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 50090-4465-0 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 50090-4465-0 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 50090-4465-0 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 50090-4465-0 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 50090-4465-0 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 50090-4465-0 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 50090-4465-0 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 50090-4465-0 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 50090-4465-0 557ba5c1ecfa…9c80585c8c6e…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203459-001 PREGABALIN PREGABALIN 25MG CAPSULE / ORAL AB 2019-07-19 A203459-002 PREGABALIN PREGABALIN 50MG CAPSULE / ORAL AB 2019-07-19 A203459-003 PREGABALIN PREGABALIN 75MG CAPSULE / ORAL AB 2019-07-19 A203459-004 PREGABALIN PREGABALIN 100MG CAPSULE / ORAL AB 2019-07-19 A203459-005 PREGABALIN PREGABALIN 150MG CAPSULE / ORAL AB 2019-07-19 A203459-006 PREGABALIN PREGABALIN 200MG CAPSULE / ORAL AB 2019-07-19 A203459-007 PREGABALIN PREGABALIN 225MG CAPSULE / ORAL AB 2019-07-19 A203459-008 PREGABALIN PREGABALIN 300MG CAPSULE / ORAL AB 2019-07-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 8 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A203459-001 PREGABALIN 25MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203459-002 PREGABALIN 50MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203459-003 PREGABALIN 75MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203459-004 PREGABALIN 100MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203459-005 PREGABALIN 150MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203459-006 PREGABALIN 200MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203459-007 PREGABALIN 225MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203459-008 PREGABALIN 300MG CAPSULE / ORAL AB 2019-07-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203459-001 PREGABALIN 25MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203459-002 PREGABALIN 50MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203459-003 PREGABALIN 75MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203459-004 PREGABALIN 100MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203459-005 PREGABALIN 150MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203459-006 PREGABALIN 200MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203459-007 PREGABALIN 225MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203459-008 PREGABALIN 300MG CAPSULE / ORAL AB 2019-07-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203459-001 PREGABALIN 25MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203459-002 PREGABALIN 50MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203459-003 PREGABALIN 75MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203459-004 PREGABALIN 100MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203459-005 PREGABALIN 150MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203459-006 PREGABALIN 200MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203459-007 PREGABALIN 225MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203459-008 PREGABALIN 300MG CAPSULE / ORAL AB 2019-07-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203459-001 PREGABALIN 25MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203459-002 PREGABALIN 50MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203459-003 PREGABALIN 75MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203459-004 PREGABALIN 100MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203459-005 PREGABALIN 150MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203459-006 PREGABALIN 200MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203459-007 PREGABALIN 225MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203459-008 PREGABALIN 300MG CAPSULE / ORAL AB 2019-07-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203459-001 PREGABALIN 25MG CAPSULE / ORAL AB 2019-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203459-002 PREGABALIN 50MG CAPSULE / ORAL AB 2019-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203459-003 PREGABALIN 75MG CAPSULE / ORAL AB 2019-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203459-004 PREGABALIN 100MG CAPSULE / ORAL AB 2019-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203459-005 PREGABALIN 150MG CAPSULE / ORAL AB 2019-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203459-006 PREGABALIN 200MG CAPSULE / ORAL AB 2019-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203459-007 PREGABALIN 225MG CAPSULE / ORAL AB 2019-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203459-008 PREGABALIN 300MG CAPSULE / ORAL AB 2019-07-19 fd3edfee7708…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 9 · 328 observed states.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-4465-0 50090446500 90 CAPSULE in 1 BOTTLE (50090-4465-0) 90 capsule 2019-08-13 0000-00-00 No No Current