Home NDC 29300-442-19 Pregabalin
Product NDC 29300-442
Requested package NDC 29300-442-19
11-digit product format 293000442
Labeler code 29300
Product ID 29300-442_18bd1b03-be06-46c7-9f4f-eec4a218ff40
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pregabalin
Dosage form CAPSULE
Route ORAL
Labeler Unichem Pharmaceuticals (USA), Inc.
Application ANDA219593
Marketing category ANDA
Marketing start 2026-08-03
Substance PREGABALIN
Active strength 100 mg/1
DEA schedule CV
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 A219593-001 PREGABALIN PREGABALIN 25MG CAPSULE / ORAL AB 2026-04-30 A219593-002 PREGABALIN PREGABALIN 50MG CAPSULE / ORAL AB 2026-04-30 A219593-003 PREGABALIN PREGABALIN 75MG CAPSULE / ORAL AB 2026-04-30 A219593-004 PREGABALIN PREGABALIN 100MG CAPSULE / ORAL AB 2026-04-30 A219593-005 PREGABALIN PREGABALIN 150MG CAPSULE / ORAL AB 2026-04-30 A219593-006 PREGABALIN PREGABALIN 200MG CAPSULE / ORAL AB 2026-04-30 A219593-007 PREGABALIN PREGABALIN 225MG CAPSULE / ORAL AB 2026-04-30 A219593-008 PREGABALIN PREGABALIN 300MG CAPSULE / ORAL AB 2026-04-30
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 A219593-001 PREGABALIN 25MG CAPSULE / ORAL AB 2026-04-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219593-002 PREGABALIN 50MG CAPSULE / ORAL AB 2026-04-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219593-003 PREGABALIN 75MG CAPSULE / ORAL AB 2026-04-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219593-004 PREGABALIN 100MG CAPSULE / ORAL AB 2026-04-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219593-005 PREGABALIN 150MG CAPSULE / ORAL AB 2026-04-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219593-006 PREGABALIN 200MG CAPSULE / ORAL AB 2026-04-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219593-007 PREGABALIN 225MG CAPSULE / ORAL AB 2026-04-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219593-008 PREGABALIN 300MG CAPSULE / ORAL AB 2026-04-30 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 A219593-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219593-002 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219593-003 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219593-004 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219593-005 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219593-006 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219593-007 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219593-008 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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 29300-442-19 29300044219 90 CAPSULE in 1 BOTTLE (29300-442-19) 90 capsule 2026-08-03 0 Current