Home NDC 27808-240 Pregabalin
Product NDC 27808-240
11-digit product format 278080240
Labeler code 27808
Product ID 27808-240_34723420-dabe-4070-83f1-5de1db603532
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pregabalin
Dosage form CAPSULE
Route ORAL
Labeler Tris Pharma Inc
Application ANDA214322
Marketing category ANDA
Marketing start 2021-07-15
Substance PREGABALIN
Active strength 225 mg/1
DEA schedule CV
NDC exclude flag No
Listing certified through 2026-12-31
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 A214322-001 PREGABALIN PREGABALIN 50MG CAPSULE / ORAL AB 2021-07-15 A214322-002 PREGABALIN PREGABALIN 75MG CAPSULE / ORAL AB 2021-07-15 A214322-003 PREGABALIN PREGABALIN 100MG CAPSULE / ORAL AB 2021-07-15 A214322-004 PREGABALIN PREGABALIN 150MG CAPSULE / ORAL AB 2021-07-15 A214322-005 PREGABALIN PREGABALIN 200MG CAPSULE / ORAL AB 2021-07-15 A214322-006 PREGABALIN PREGABALIN 225MG CAPSULE / ORAL AB 2021-07-15 A214322-007 PREGABALIN PREGABALIN 300MG CAPSULE / ORAL AB 2021-07-15 A214322-008 PREGABALIN PREGABALIN 25MG CAPSULE / ORAL AB 2024-09-26
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 7 · 241 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 A214322-001 PREGABALIN 50MG CAPSULE / ORAL AB 2021-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214322-002 PREGABALIN 75MG CAPSULE / ORAL AB 2021-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214322-003 PREGABALIN 100MG CAPSULE / ORAL AB 2021-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214322-004 PREGABALIN 150MG CAPSULE / ORAL AB 2021-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214322-005 PREGABALIN 200MG CAPSULE / ORAL AB 2021-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214322-006 PREGABALIN 225MG CAPSULE / ORAL AB 2021-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214322-007 PREGABALIN 300MG CAPSULE / ORAL AB 2021-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214322-008 PREGABALIN 25MG CAPSULE / ORAL AB 2024-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214322-001 PREGABALIN 50MG CAPSULE / ORAL AB 2021-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214322-002 PREGABALIN 75MG CAPSULE / ORAL AB 2021-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214322-003 PREGABALIN 100MG CAPSULE / ORAL AB 2021-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214322-004 PREGABALIN 150MG CAPSULE / ORAL AB 2021-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214322-005 PREGABALIN 200MG CAPSULE / ORAL AB 2021-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214322-006 PREGABALIN 225MG CAPSULE / ORAL AB 2021-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214322-007 PREGABALIN 300MG CAPSULE / ORAL AB 2021-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214322-008 PREGABALIN 25MG CAPSULE / ORAL AB 2024-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214322-001 PREGABALIN 50MG CAPSULE / ORAL AB 2021-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214322-002 PREGABALIN 75MG CAPSULE / ORAL AB 2021-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214322-003 PREGABALIN 100MG CAPSULE / ORAL AB 2021-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214322-004 PREGABALIN 150MG CAPSULE / ORAL AB 2021-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214322-005 PREGABALIN 200MG CAPSULE / ORAL AB 2021-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214322-006 PREGABALIN 225MG CAPSULE / ORAL AB 2021-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214322-007 PREGABALIN 300MG CAPSULE / ORAL AB 2021-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214322-008 PREGABALIN 25MG CAPSULE / ORAL AB 2024-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214322-001 PREGABALIN 50MG CAPSULE / ORAL AB 2021-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214322-002 PREGABALIN 75MG CAPSULE / ORAL AB 2021-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214322-003 PREGABALIN 100MG CAPSULE / ORAL AB 2021-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214322-004 PREGABALIN 150MG CAPSULE / ORAL AB 2021-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214322-005 PREGABALIN 200MG CAPSULE / ORAL AB 2021-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214322-006 PREGABALIN 225MG CAPSULE / ORAL AB 2021-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214322-007 PREGABALIN 300MG CAPSULE / ORAL AB 2021-07-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214322-008 PREGABALIN 25MG CAPSULE / ORAL AB 2024-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214322-001 PREGABALIN 50MG CAPSULE / ORAL AB 2021-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214322-002 PREGABALIN 75MG CAPSULE / ORAL AB 2021-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214322-003 PREGABALIN 100MG CAPSULE / ORAL AB 2021-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214322-004 PREGABALIN 150MG CAPSULE / ORAL AB 2021-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214322-005 PREGABALIN 200MG CAPSULE / ORAL AB 2021-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214322-006 PREGABALIN 225MG CAPSULE / ORAL AB 2021-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214322-007 PREGABALIN 300MG CAPSULE / ORAL AB 2021-07-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214322-008 PREGABALIN 25MG CAPSULE / ORAL AB 2024-09-26 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 7 · 241 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Pregabalin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREGABALIN 225 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 · 7 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 483438 Internal RxNorm lookup 483440 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 27808-240-01 Pregabalin 90 in 1 BOTTLE CAPSULE 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27808-240 PREGABALIN CAPSULE [TRIS PHARMA INC] 3 Current NDC, Legacy NDC, 1 package rows 20240619_62aa850d-199c-44d5-a730-45f43efa850e.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 27808-240-01 27808024001 90 CAPSULE in 1 BOTTLE (27808-240-01) 90 capsule 2022-02-01 0000-00-00 No No Current