Home NDC 58151-244 Lyrica
Product NDC 58151-244
11-digit product format 581510244
Labeler code 58151
Product ID 58151-244_1c2af07d-faf4-4fc7-b724-c5166746956d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PREGABALIN
Dosage form SOLUTION
Route ORAL
Labeler Viatris Specialty LLC
Application NDA022488
Marketing category NDA
Marketing start 2024-10-22
Substance PREGABALIN
Active strength 20 mg/mL
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 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022488-001 LYRICA PREGABALIN 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022488-001 AA
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 2 · 43 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 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL RLD, RS 2010-01-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# 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 N022488-001 6001876*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022488-001 6197819*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022488-001 RE41920*PED 2019-06-30 Pediatric extension 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N022488-001 6001876*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022488-001 6197819*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022488-001 RE41920*PED 2019-06-30 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022488-001 6001876*PED 2019-06-30 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022488-001 6197819*PED 2019-06-30 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022488-001 RE41920*PED 2019-06-30 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022488-001 6001876*PED 2019-06-30 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022488-001 6197819*PED 2019-06-30 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022488-001 RE41920*PED 2019-06-30 Pediatric extension ea99ee380514…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 64 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Lyrica
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PREGABALIN 20 mg/mL
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 · 18 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 483438 Internal RxNorm lookup 483440 Internal RxNorm lookup 483442 Internal RxNorm lookup 483444 Internal RxNorm lookup 483446 Internal RxNorm lookup 483448 Internal RxNorm lookup 483450 Internal RxNorm lookup 577127 Internal RxNorm lookup 607018 Internal RxNorm lookup 607020 Internal RxNorm lookup 607022 Internal RxNorm lookup 607024 Internal RxNorm lookup 607026 Internal RxNorm lookup 607028 Internal RxNorm lookup 607033 Internal RxNorm lookup 607038 Internal RxNorm lookup 898715 Internal RxNorm lookup 898718 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 58151-244-35 Lyrica 473 mL in 1 BOTTLE SOLUTION 473 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58151-244 LYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [VIATRIS SPECIALTY LLC] 11 Current NDC, 1 package rows 20250510_d4734e7d-5079-455e-8ff5-8f4539c998a9.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58151-244-35 58151024435 473 mL in 1 BOTTLE (58151-244-35) 473 ml 2024-10-22 No No Current