Home NDC 82968-009-02 PREGABALIN
Product NDC 82968-009
Requested package NDC 82968-009-02
11-digit product format 829680009
Labeler code 82968
Product ID 82968-009_4c41b54b-827a-1d04-e063-6394a90a55ea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PREGABALIN
Dosage form CAPSULE
Route ORAL
Labeler FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED
Application ANDA218529
Marketing category ANDA
Marketing start 2026-02-24
Substance PREGABALIN
Active strength 100 mg/1
DEA schedule CV
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 A218529-001 PREGABALIN PREGABALIN 25MG CAPSULE / ORAL AB 2026-02-24 A218529-002 PREGABALIN PREGABALIN 50MG CAPSULE / ORAL AB 2026-02-24 A218529-003 PREGABALIN PREGABALIN 75MG CAPSULE / ORAL AB 2026-02-24 A218529-004 PREGABALIN PREGABALIN 100MG CAPSULE / ORAL AB 2026-02-24 A218529-005 PREGABALIN PREGABALIN 150MG CAPSULE / ORAL AB 2026-02-24 A218529-006 PREGABALIN PREGABALIN 200MG CAPSULE / ORAL AB 2026-02-24 A218529-007 PREGABALIN PREGABALIN 225MG CAPSULE / ORAL AB 2026-02-24 A218529-008 PREGABALIN PREGABALIN 300MG CAPSULE / ORAL AB 2026-02-24
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.
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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-001 PREGABALIN 25MG CAPSULE / ORAL AB 2026-02-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-002 PREGABALIN 50MG CAPSULE / ORAL AB 2026-02-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-003 PREGABALIN 75MG CAPSULE / ORAL AB 2026-02-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-004 PREGABALIN 100MG CAPSULE / ORAL AB 2026-02-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-005 PREGABALIN 150MG CAPSULE / ORAL AB 2026-02-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-006 PREGABALIN 200MG CAPSULE / ORAL AB 2026-02-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-007 PREGABALIN 225MG CAPSULE / ORAL AB 2026-02-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-008 PREGABALIN 300MG CAPSULE / ORAL AB 2026-02-24 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-002 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-003 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-004 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-005 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-006 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-007 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218529-008 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base PREGABALIN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREGABALIN 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 55JG375S6M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 483438 Internal RxNorm lookup 483440 Internal RxNorm lookup 483442 Internal RxNorm lookup 483444 Internal RxNorm lookup 483446 Internal RxNorm lookup 483448 Internal RxNorm lookup 483450 Internal RxNorm lookup 577127 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82968-009-02 PREGABALIN 90 in 1 BOTTLE CAPSULE 90 1 82968-009-04 PREGABALIN 100 in 1 CARTON CAPSULE 100 1 82968-009-04 PREGABALIN 1 in 1 BLISTER PACK CAPSULE 1 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82968-009-02 82968000902 90 CAPSULE in 1 BOTTLE (82968-009-02) 90 capsule 2026-02-24 No No Current