Home NDC 76420-247 Pregabalin
Product NDC 76420-247
11-digit product format 764200247
Labeler code 76420
Product ID 76420-247_e824474c-f378-a1c2-e053-2995a90a0bed
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pregabalin
Dosage form CAPSULE
Route ORAL
Labeler Asclemed USA, Inc.
Application ANDA212865
Marketing category ANDA
Marketing start 2020-03-31
Marketing end 0000-00-00
Substance PREGABALIN
Active strength 50 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 · 8 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 76420-247-30 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 76420-247-90 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 76420-247-60 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 76420-247-30 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 76420-247-90 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 76420-247-60 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212865-001 PREGABALIN PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 A212865-002 PREGABALIN PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 A212865-003 PREGABALIN PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 A212865-004 PREGABALIN PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 4 · 148 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 A212865-001 PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212865-002 PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212865-003 PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212865-004 PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212865-001 PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212865-002 PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212865-003 PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212865-004 PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212865-001 PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212865-002 PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212865-003 PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212865-004 PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212865-001 PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212865-002 PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212865-003 PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212865-004 PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212865-001 PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212865-002 PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212865-003 PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212865-004 PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212865-001 PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212865-002 PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212865-003 PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212865-004 PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212865-001 PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212865-002 PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212865-003 PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212865-004 PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212865-001 PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212865-002 PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212865-003 PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212865-004 PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212865-001 PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212865-002 PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212865-003 PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212865-004 PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212865-001 PREGABALIN 50MG CAPSULE / ORAL AB 2020-03-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212865-002 PREGABALIN 75MG CAPSULE / ORAL AB 2020-03-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212865-003 PREGABALIN 100MG CAPSULE / ORAL AB 2020-03-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212865-004 PREGABALIN 150MG CAPSULE / ORAL AB 2020-03-20 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 148 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-247 PREGABALIN CAPSULE [ASCLEMED USA, INC.] 2 Legacy NDC 20220910_e750115a-3f99-497c-ab86-359d76a230f1.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 · 1 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 76420-247-30 76420024730 90 CAPSULE in 1 BOTTLE (76420-247-30) 90 capsule 2022-07-25 0000-00-00 No No Current 76420-247-60 76420024760 90 CAPSULE in 1 BOTTLE (76420-247-60) 90 capsule 2022-07-25 0000-00-00 No No Current 76420-247-90 76420024790 60 CAPSULE in 1 BOTTLE (76420-247-90) 60 capsule 2022-07-25 0000-00-00 No No Current