Home NDC 63629-4181 Lyrica
Product NDC 63629-4181
11-digit product format 636294181
Labeler code 63629
Product ID 63629-4181_76c18e3c-f126-4a75-8802-a6c77161e94e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PREGABALIN
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application NDA021446
Marketing category NDA
Marketing start 2004-12-30
Marketing end 0000-00-00
Substance PREGABALIN
Active strength 150 mg/1
DEA schedule CV
NDC exclude flag No
Listing certified through 2021-12-31
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 3 · 138 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 344 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 2026-09-14 22:38:34 2026-08 N021446-001 LYRICA 25MG CAPSULE / ORAL AB RLD 2004-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021446-002 LYRICA 50MG CAPSULE / ORAL AB RLD 2004-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021446-003 LYRICA 75MG CAPSULE / ORAL AB RLD 2004-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021446-004 LYRICA 100MG CAPSULE / ORAL AB RLD 2004-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021446-005 LYRICA 150MG CAPSULE / ORAL AB RLD 2004-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021446-006 LYRICA 200MG CAPSULE / ORAL AB RLD 2004-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021446-007 LYRICA 225MG CAPSULE / ORAL AB RLD 2004-12-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021446-008 LYRICA 300MG CAPSULE / ORAL AB RLD, RS 2004-12-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021446-001 LYRICA 25MG CAPSULE / ORAL AB RLD 2004-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021446-002 LYRICA 50MG CAPSULE / ORAL AB RLD 2004-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021446-003 LYRICA 75MG CAPSULE / ORAL AB RLD 2004-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021446-004 LYRICA 100MG CAPSULE / ORAL AB RLD 2004-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021446-005 LYRICA 150MG CAPSULE / ORAL AB RLD 2004-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021446-006 LYRICA 200MG CAPSULE / ORAL AB RLD 2004-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021446-007 LYRICA 225MG CAPSULE / ORAL AB RLD 2004-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021446-008 LYRICA 300MG CAPSULE / ORAL AB RLD, RS 2004-12-30 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 9 · 336 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-4181-1 2020-10-16 These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004 63629-4181-2 2020-10-16 These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004 63629-4181-3 2020-10-16 These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004 63629-4181-4 2020-10-16 These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004 63629-4181-5 2020-10-16 These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004 63629-4181-1 2020-01-31 These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004 63629-4181-2 2020-01-31 These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004 63629-4181-3 2020-01-31 These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004 63629-4181-4 2020-01-31 These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004 63629-4181-5 2020-01-31 These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CV LYRICA (pregabalin) Oral Solution, CV Initial U.S. Approval: 2004
DailyMed Socrata Ingredients# 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 63629-4181-1 63629418101 56 CAPSULE in 1 BOTTLE (63629-4181-1) 56 capsule 2010-03-29 0000-00-00 No No Current 63629-4181-2 63629418102 30 CAPSULE in 1 BOTTLE (63629-4181-2) 30 capsule 2010-03-29 0000-00-00 No No Current 63629-4181-3 63629418103 60 CAPSULE in 1 BOTTLE (63629-4181-3) 60 capsule 2010-03-29 0000-00-00 No No Current 63629-4181-4 63629418104 90 CAPSULE in 1 BOTTLE (63629-4181-4) 90 capsule 2010-03-29 0000-00-00 No No Current 63629-4181-5 63629418105 28 CAPSULE in 1 BOTTLE (63629-4181-5) 28 capsule 2010-03-29 0000-00-00 No No Current