Home NDC 0054-3090 Butorphanol Tartrate
Product NDC 0054-3090
11-digit product format 000543090
Labeler code 0054
Product ID 0054-3090_57de4cd2-a163-4ac7-9e86-a04355a00d78
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butorphanol Tartrate
Dosage form SPRAY, METERED
Route NASAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA075824
Marketing category ANDA
Marketing start 2002-03-12
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 2027-12-31
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 A075824-001 BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-03-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075824-001 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 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-03-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-03-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-03-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB RS 2002-03-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075824-001 BUTORPHANOL TARTRATE 1MG/SPRAY SPRAY, METERED / NASAL AB 2002-03-12 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 2027-12-31 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 0054-3090-36 Butorphanol Tartrate 1 in 1 CONTAINER SPRAY, METERED 1 20 0054-3090-36 Butorphanol Tartrate 2.5 mL in 1 BOTTLE, SPRAY SPRAY, METERED 2.5 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BUTORPHANOL TARTRATE ACTIVE INGREDIENT 2L7I72RUHN BUTORPHANOL TARTRATE SPRAY, METERED [ROXANE LABORATORIES, INC] 4 BUTORPHANOL ACTIVE MOIETY QV897JC36D BUTORPHANOL TARTRATE SPRAY, METERED [ROXANE LABORATORIES, INC] 4 BENZETHONIUM CHLORIDE INACTIVE INGREDIENT PH41D05744 BUTORPHANOL TARTRATE SPRAY, METERED [ROXANE LABORATORIES, INC] 4 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP BUTORPHANOL TARTRATE SPRAY, METERED [ROXANE LABORATORIES, INC] 4 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB BUTORPHANOL TARTRATE SPRAY, METERED [ROXANE LABORATORIES, INC] 4 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X BUTORPHANOL TARTRATE SPRAY, METERED [ROXANE LABORATORIES, INC] 4 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I BUTORPHANOL TARTRATE SPRAY, METERED [ROXANE LABORATORIES, INC] 4 WATER INACTIVE INGREDIENT 059QF0KO0R BUTORPHANOL TARTRATE SPRAY, METERED [ROXANE LABORATORIES, INC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-3090 BUTORPHANOL TARTRATE SPRAY, METERED [HIKMA PHARMACEUTICALS USA INC.] 17 Current NDC, Legacy NDC, 2 package rows 20250327_5a50d22e-acbe-4b15-9ed6-70713378408a.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 Marketing start Marketing end Sample Exclude flag Status 0054-3090-36 00054309036 1 BOTTLE, SPRAY in 1 CONTAINER (0054-3090-36) / 2.5 mL in 1 BOTTLE, SPRAY 2002-03-12 0000-00-00 No No Current