Home NDC 60505-0813 Butorphanol Tartrate
Product NDC 60505-0813
11-digit product format 605050813
Labeler code 60505
Product ID 60505-0813_88ae38c6-790d-dafe-6cef-646b84e274ec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butorphanol Tartrate
Dosage form SPRAY
Route NASAL
Labeler Apotex Corp.
Application ANDA075499
Marketing category ANDA
Marketing start 2002-12-04
Substance BUTORPHANOL TARTRATE
Active strength 10 mg/mL
Pharmacologic classes Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]
DEA schedule CIV
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 42 .
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 A075499-001 BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075499-001 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 · 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 2026-08-18 06:07:40 2026-07 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075499-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-12-04 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Butorphanol Tartrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUTORPHANOL TARTRATE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2L7I72RUHN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 886634 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 60505-0813-1 Butorphanol Tartrate 2.5 mL in 1 BOTTLE, SPRAY SPRAY 2.5 23 60505-0813-1 Butorphanol Tartrate 1 in 1 CONTAINER SPRAY 1 23
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-0813 BUTORPHANOL TARTRATE (BUTORPHANOL TARTRATE ) SPRAY [APOTEX CORP.] 18 Current NDC, Legacy NDC, 2 package rows 20240118_b8e48063-0b40-ee43-85c1-4ef2de80c404.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 Marketing start Marketing end Sample Exclude flag Status 60505-0813-1 60505081301 1 BOTTLE, SPRAY in 1 CONTAINER (60505-0813-1) / 2.5 mL in 1 BOTTLE, SPRAY 2002-12-04 0000-00-00 No No Current