Home NDC 57664-762 Levorphanol Tartrate
Product NDC 57664-762
11-digit product format 576640762
Labeler code 57664
Product ID 57664-762_48471dc2-bdd9-2263-e063-6294a90a9e03
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levorphanol Tartrate
Dosage form TABLET
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA213906
Marketing category ANDA
Marketing start 2022-04-26
Substance LEVORPHANOL TARTRATE
Active strength 2 mg/1
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213906-001 LEVORPHANOL TARTRATE LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 A213906-002 LEVORPHANOL TARTRATE LEVORPHANOL TARTRATE 3MG TABLET / ORAL RS 2023-04-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213906-001 AB
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 · 55 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 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213906-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL RS 2023-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213906-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL RS 2023-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213906-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL RS 2023-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213906-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB 2023-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213906-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB 2023-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213906-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB 2023-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213906-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB 2023-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213906-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB 2023-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213906-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB 2023-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213906-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB 2023-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213906-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB 2023-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213906-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB 2023-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213906-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB 2023-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213906-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB 2023-04-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213906-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB 2023-04-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A213906-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB 2023-04-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A213906-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB 2023-04-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213906-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2021-06-17 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 51 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Levorphanol Tartrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVORPHANOL TARTRATE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04WQU6T9QI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197873 Internal RxNorm lookup 2058845 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 57664-762-88 Levorphanol Tartrate 100 in 1 BOTTLE TABLET 100 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57664-762 LEVORPHANOL TARTRATE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] 9 Current NDC, Legacy NDC, 1 package rows 20240831_438cf3ea-04fe-4626-9f0f-adcda7633651.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 57664-762-88 57664076288 100 TABLET in 1 BOTTLE (57664-762-88) 100 tablet 2022-04-26 0000-00-00 No No Current