Home NDC 0143-9864 Butorphanol Tartrate
Product NDC 0143-9864
11-digit product format 001439864
Labeler code 0143
Product ID 0143-9864_b7be42f0-5b59-4a5a-a667-dfa81ff08b2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butorphanol Tartrate
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA078400
Marketing category ANDA
Marketing start 2009-05-01
Substance BUTORPHANOL TARTRATE
Active strength 1 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078400-001 BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 A078400-002 BUTORPHANOL TARTRATE BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 84 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 A078400-001 BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A078400-002 BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078400-001 BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078400-002 BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078400-001 BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078400-002 BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078400-001 BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078400-002 BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078400-001 BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078400-002 BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078400-001 BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078400-002 BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078400-001 BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078400-002 BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078400-001 BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078400-002 BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078400-001 BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078400-002 BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078400-001 BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078400-002 BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078400-001 BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078400-002 BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078400-001 BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078400-002 BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078400-001 BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078400-002 BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078400-001 BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078400-002 BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078400-001 BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078400-002 BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078400-001 BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078400-002 BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078400-001 BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078400-002 BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078400-001 BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078400-002 BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078400-001 BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078400-002 BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078400-001 BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP 2009-05-01 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078400-002 BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP 2009-05-01 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 1 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 886627 Internal RxNorm lookup 1728351 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 0143-9864-10 Butorphanol Tartrate 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9864 BUTORPHANOL TARTRATE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 11 Current NDC, Legacy NDC, 1 package rows 20240413_bded5531-8847-4576-9a29-3e44f979d2e0.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 0143-9864-10 00143986410 1 mL in 1 VIAL, SINGLE-DOSE (0143-9864-10) 1 ml 2009-05-01 0000-00-00 No No Current