Home NDC 72989-417 Levorphanol Tartrate
Product NDC 72989-417
11-digit product format 729890417
Labeler code 72989
Product ID 72989-417_13e399bd-0f7e-46d8-89fe-cc2c5854f3c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levorphanol Tartrate
Dosage form TABLET
Route ORAL
Labeler ACERTIS PHARMACEUTICALS, LLC
Application ANDA211484
Marketing category ANDA
Marketing start 2025-07-14
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 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 A211484-001 LEVORPHANOL TARTRATE LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211484-001 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 · 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 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211484-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2018-12-13 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 A211484-001 CGT 2019-06-11 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 A211484-001 CGT 2019-06-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211484-001 CGT 2019-06-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211484-001 CGT 2019-06-11 ea99ee380514…
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 Levorphanol Tartrate
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197873 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 72989-417-10 Levorphanol Tartrate 100 in 1 BOTTLE TABLET 100 1
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Levorphanol Tartrate LEVORPHANOL TARTRATE Bryant Ranch Prepack deed8652-9b9d-48b4-8c3e-9fdd7c46237e 2025-11-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211484 application number: ANDA211484 Levorphanol Tartrate LEVORPHANOL TARTRATE Virtus Pharmaceuticals, LLC 6e7ca993-c8b9-4510-a2b0-5bcc678d2571 2025-07-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211484 application number: ANDA211484 Levorphanol Tartrate LEVORPHANOL TARTRATE ACERTIS PHARMACEUTICALS, LLC 113a713f-830b-481c-bfa6-d44e3ac27f80 2025-06-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211484 application number: ANDA211484 ndc (product): 72989-417
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72989-417-10 72989041710 100 TABLET in 1 BOTTLE (72989-417-10) 100 tablet 2025-07-14 No No Current