Home NDC 0071-1020 Lyrica
Product NDC 0071-1020
11-digit product format 000711020
Labeler code 0071
Product ID 0071-1020_b9b1285a-2cb3-4789-8b0e-8d5e1b253534
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PREGABALIN
Dosage form SOLUTION
Route ORAL
Labeler Parke-Davis Div of Pfizer Inc
Application NDA022488
Marketing category NDA
Marketing start 2010-01-04
Marketing end 0000-00-00
Substance PREGABALIN
Active strength 20 mg/mL
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 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 0071-1020 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0071-1020 0071-1020-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 41 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 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…2022-09-29 23:25 UTC 2022-09 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022488-001 LYRICA 20MG/ML SOLUTION / ORAL AA RLD, RS 2010-01-04 cb3db0bc1861…
Observed Orange Book normalized TE history# 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0071-1020-01 Lyrica 473 mL in 1 BOTTLE SOLUTION 473 59
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0071-1020 LYRICA (PREGABALIN) CAPSULE LYRICA (PREGABALIN) SOLUTION [PARKE-DAVIS DIV OF PFIZER INC] 54 Legacy NDC, 1 package rows 20250510_60185c88-ecfd-46f9-adb9-b97c6b00a553.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 · 3 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 0071-1020-01 00071102001 473 mL in 1 BOTTLE (0071-1020-01) 473 ml 2010-01-04 0000-00-00 No No Current