Home NDC 55289-255-30 Lyrica
Product NDC 55289-255
Requested package NDC 55289-255-30
11-digit product format 552890255
Labeler code 55289
Product ID 55289-255_d9a5c1b0-3b71-dbab-e053-2995a90abf9a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PREGABALIN
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application NDA021446
Marketing category NDA
Marketing start 2004-12-30
Marketing end 0000-00-00
Substance PREGABALIN
Active strength 300 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N021446-001 LYRICA PREGABALIN 25MG CAPSULE / ORAL AB RLD 2004-12-30 N021446-002 LYRICA PREGABALIN 50MG CAPSULE / ORAL AB RLD 2004-12-30 N021446-003 LYRICA PREGABALIN 75MG CAPSULE / ORAL AB RLD 2004-12-30 N021446-004 LYRICA PREGABALIN 100MG CAPSULE / ORAL AB RLD 2004-12-30 N021446-005 LYRICA PREGABALIN 150MG CAPSULE / ORAL AB RLD 2004-12-30 N021446-006 LYRICA PREGABALIN 200MG CAPSULE / ORAL AB RLD 2004-12-30 N021446-007 LYRICA PREGABALIN 225MG CAPSULE / ORAL AB RLD 2004-12-30 N021446-008 LYRICA PREGABALIN 300MG CAPSULE / ORAL AB RLD, RS 2004-12-30
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.
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 2026-02-19 14:30 UTC 2026-02 N021446-001 LYRICA 25MG CAPSULE / ORAL AB RLD 2004-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021446-002 LYRICA 50MG CAPSULE / ORAL AB RLD 2004-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021446-003 LYRICA 75MG CAPSULE / ORAL AB RLD 2004-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021446-004 LYRICA 100MG CAPSULE / ORAL AB RLD 2004-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021446-005 LYRICA 150MG CAPSULE / ORAL AB RLD 2004-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021446-006 LYRICA 200MG CAPSULE / ORAL AB RLD 2004-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021446-007 LYRICA 225MG CAPSULE / ORAL AB RLD 2004-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021446-008 LYRICA 300MG CAPSULE / ORAL AB RLD, RS 2004-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021446-001 LYRICA 25MG CAPSULE / ORAL AB RLD 2004-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021446-002 LYRICA 50MG CAPSULE / ORAL AB RLD 2004-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021446-003 LYRICA 75MG CAPSULE / ORAL AB RLD 2004-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021446-004 LYRICA 100MG CAPSULE / ORAL AB RLD 2004-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021446-005 LYRICA 150MG CAPSULE / ORAL AB RLD 2004-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021446-006 LYRICA 200MG CAPSULE / ORAL AB RLD 2004-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021446-007 LYRICA 225MG CAPSULE / ORAL AB RLD 2004-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021446-008 LYRICA 300MG CAPSULE / ORAL AB RLD, RS 2004-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021446-001 LYRICA 25MG CAPSULE / ORAL AB RLD 2004-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021446-002 LYRICA 50MG CAPSULE / ORAL AB RLD 2004-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021446-003 LYRICA 75MG CAPSULE / ORAL AB RLD 2004-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021446-004 LYRICA 100MG CAPSULE / ORAL AB RLD 2004-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021446-005 LYRICA 150MG CAPSULE / ORAL AB RLD 2004-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021446-006 LYRICA 200MG CAPSULE / ORAL AB RLD 2004-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021446-007 LYRICA 225MG CAPSULE / ORAL AB RLD 2004-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021446-008 LYRICA 300MG CAPSULE / ORAL AB RLD, RS 2004-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021446-001 LYRICA 25MG CAPSULE / ORAL AB RLD 2004-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021446-002 LYRICA 50MG CAPSULE / ORAL AB RLD 2004-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021446-003 LYRICA 75MG CAPSULE / ORAL AB RLD 2004-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021446-004 LYRICA 100MG CAPSULE / ORAL AB RLD 2004-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021446-005 LYRICA 150MG CAPSULE / ORAL AB RLD 2004-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021446-006 LYRICA 200MG CAPSULE / ORAL AB RLD 2004-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021446-007 LYRICA 225MG CAPSULE / ORAL AB RLD 2004-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021446-008 LYRICA 300MG CAPSULE / ORAL AB RLD, RS 2004-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021446-001 LYRICA 25MG CAPSULE / ORAL AB RLD 2004-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021446-002 LYRICA 50MG CAPSULE / ORAL AB RLD 2004-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021446-003 LYRICA 75MG CAPSULE / ORAL AB RLD 2004-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021446-004 LYRICA 100MG CAPSULE / ORAL AB RLD 2004-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021446-005 LYRICA 150MG CAPSULE / ORAL AB RLD 2004-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021446-006 LYRICA 200MG CAPSULE / ORAL AB RLD 2004-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021446-007 LYRICA 225MG CAPSULE / ORAL AB RLD 2004-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021446-008 LYRICA 300MG CAPSULE / ORAL AB RLD, RS 2004-12-30 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 8 · 320 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 96 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021446-001 6001876*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-001 6197819*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-001 RE41920*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-002 6001876*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-002 6197819*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-002 RE41920*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-003 6001876*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-003 6197819*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-003 RE41920*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-004 6001876*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-004 6197819*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-004 RE41920*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-005 6001876*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-005 6197819*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-005 RE41920*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-006 6001876*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-006 6197819*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-006 RE41920*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-007 6001876*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-007 6197819*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-007 RE41920*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-008 6001876*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-008 6197819*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021446-008 RE41920*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021446-001 6001876*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021446-001 6197819*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021446-001 RE41920*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021446-002 6001876*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021446-002 6197819*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021446-002 RE41920*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021446-003 6001876*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021446-003 6197819*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021446-003 RE41920*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021446-004 6001876*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021446-004 6197819*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021446-004 RE41920*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021446-005 6001876*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021446-005 6197819*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021446-005 RE41920*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021446-006 6001876*PED 2019-06-30 Pediatric extension 3f01610625f2…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 13 · 512 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PREGABALIN ACTIVE INGREDIENT 55JG375S6M LYRICA (PREGABALIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 PREGABALIN ACTIVE MOIETY 55JG375S6M LYRICA (PREGABALIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 LYRICA (PREGABALIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 LYRICA (PREGABALIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 GELATIN INACTIVE INGREDIENT 2G86QN327L LYRICA (PREGABALIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LYRICA (PREGABALIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T LYRICA (PREGABALIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 LYRICA (PREGABALIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 SHELLAC INACTIVE INGREDIENT 46N107B71O LYRICA (PREGABALIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LYRICA (PREGABALIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J LYRICA (PREGABALIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LYRICA (PREGABALIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 TALC INACTIVE INGREDIENT 7SEV7J4R1U LYRICA (PREGABALIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LYRICA (PREGABALIN) CAPSULE [PD-RX PHARMACEUTICALS, INC.] 14
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 55289-255-30 55289025530 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-255-30) 30 capsule 2011-07-12 0000-00-00 No No Current