Home NDC 59762-1576 Pregabalin
Product NDC 59762-1576
11-digit product format 597621576
Labeler code 59762
Product ID 59762-1576_7aa334e7-3c46-4680-a266-9049af3bf566
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pregabalin
Dosage form SOLUTION
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA022488
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2019-07-29
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 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.
Additional Listing Data#
Finished product Yes
Brand name base Pregabalin
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 898715 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 59762-1576-1 Pregabalin 473 mL in 1 BOTTLE SOLUTION 473 13 59762-1576-1 Pregabalin 1 in 1 CARTON SOLUTION 1 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-1576 PREGABALIN CAPSULE PREGABALIN SOLUTION [MYLAN PHARMACEUTICALS INC.] 12 Current NDC, Legacy NDC, 2 package rows 20250503_ebe34db4-816d-4f0a-adbb-826693662754.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 Marketing end Sample Exclude flag Status 59762-1576-1 59762157601 1 BOTTLE in 1 CARTON (59762-1576-1) / 473 mL in 1 BOTTLE 1 bottle 2019-07-29 0000-00-00 No No Current