Home NDC 63629-2093 Levorphanol Tartrate
Product NDC 63629-2093
11-digit product format 636292093
Labeler code 63629
Product ID 63629-2093_46b0156b-828d-4997-bc71-e4e5471b9883
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levorphanol Tartrate
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA213479
Marketing category ANDA
Marketing start 2019-05-20
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213479-001 LEVORPHANOL TARTRATE LEVORPHANOL TARTRATE 2MG TABLET / ORAL BX 2020-07-01 A213479-002 LEVORPHANOL TARTRATE LEVORPHANOL TARTRATE 3MG TABLET / ORAL BX 2021-01-12 A213479-003 LEVORPHANOL TARTRATE LEVORPHANOL TARTRATE 1MG TABLET / ORAL BX 2021-07-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 3 · 105 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 A213479-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL BX 2020-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213479-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL BX 2021-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213479-003 LEVORPHANOL TARTRATE 1MG TABLET / ORAL BX 2021-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213479-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL BX 2020-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213479-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL BX 2021-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213479-003 LEVORPHANOL TARTRATE 1MG TABLET / ORAL BX 2021-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213479-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL BX 2020-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213479-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL BX 2021-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213479-003 LEVORPHANOL TARTRATE 1MG TABLET / ORAL BX 2021-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213479-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2020-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213479-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB RS 2021-01-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213479-003 LEVORPHANOL TARTRATE 1MG TABLET / ORAL 2021-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213479-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2020-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213479-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB RS 2021-01-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213479-003 LEVORPHANOL TARTRATE 1MG TABLET / ORAL 2021-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213479-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2020-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213479-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB RS 2021-01-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213479-003 LEVORPHANOL TARTRATE 1MG TABLET / ORAL 2021-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213479-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2020-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213479-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB RS 2021-01-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213479-003 LEVORPHANOL TARTRATE 1MG TABLET / ORAL 2021-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213479-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2020-07-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213479-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB RS 2021-01-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213479-003 LEVORPHANOL TARTRATE 1MG TABLET / ORAL 2021-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213479-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2020-07-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213479-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB RS 2021-01-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213479-003 LEVORPHANOL TARTRATE 1MG TABLET / ORAL 2021-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213479-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2020-07-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213479-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB RS 2021-01-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213479-003 LEVORPHANOL TARTRATE 1MG TABLET / ORAL 2021-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213479-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2020-07-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213479-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB RS 2021-01-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213479-003 LEVORPHANOL TARTRATE 1MG TABLET / ORAL 2021-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213479-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2020-07-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213479-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB RS 2021-01-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213479-003 LEVORPHANOL TARTRATE 1MG TABLET / ORAL 2021-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213479-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2020-07-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213479-002 LEVORPHANOL TARTRATE 3MG TABLET / ORAL AB RS 2021-01-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213479-003 LEVORPHANOL TARTRATE 1MG TABLET / ORAL 2021-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213479-001 LEVORPHANOL TARTRATE 2MG TABLET / ORAL AB 2020-07-01 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 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 · 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 63629-2093-1 Levorphanol Tartrate 100 in 1 BOTTLE TABLET 100 106
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-2093 LEVORPHANOL TARTRATE TABLET [BRYANT RANCH PREPACK] 105 Current NDC, Legacy NDC, 1 package rows 20240816_d7587868-561c-4e04-b02c-36a4b653a762.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 63629-2093-1 63629209301 100 TABLET in 1 BOTTLE (63629-2093-1) 100 tablet 2024-08-08 0000-00-00 No No Current