Home DailyMed a3e84a2a-baba-40a9-a28b-e15168906635 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:23:10
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
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.
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.