Home NDC 67877-457-47 Pregabalin
Product NDC 67877-457
Requested package NDC 67877-457-47
11-digit product format 678770457
Labeler code 67877
Product ID 67877-457_59a80208-5cc1-476c-a24b-296bc68e1e0d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pregabalin
Dosage form SOLUTION
Route ORAL
Labeler Ascend Laboratories, LLC
Application ANDA207623
Marketing category ANDA
Marketing start 2019-07-21
Substance PREGABALIN
Active strength 20 mg/mL
DEA schedule CV
NDC exclude flag No
Listing certified through 2027-12-31
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 A207623-001 PREGABALIN PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207623-001 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 · 42 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 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207623-001 PREGABALIN 20MG/ML SOLUTION / ORAL AA 2019-07-19 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 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 67877-457-47 Pregabalin 473 mL in 1 BOTTLE SOLUTION 473 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67877-457 PREGABALIN SOLUTION [ASCEND LABORATORIES, LLC] 15 Current NDC, Legacy NDC, 1 package rows 20231214_1b731dd5-b000-4c38-bfc8-2505b076e316.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 · 1 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 67877-457-47 67877045747 473 mL in 1 BOTTLE (67877-457-47) 473 ml 2019-07-21 0000-00-00 No No Current