Home NDC 0409-1623 Butorphanol Tartrate
Product NDC 0409-1623
11-digit product format 004091623
Labeler code 0409
Product ID 0409-1623_280bcddf-00c7-4c78-a108-f86ce2d30f41
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butorphanol Tartrate
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA074626
Marketing category ANDA
Marketing start 2005-09-23
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 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE BUTORPHANOL TARTRATE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23
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 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 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 2027-12-31 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 886627 Internal RxNorm lookup 1728351 Internal RxNorm lookup 1728355 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 0409-1623-01 Butorphanol Tartrate 10 in 1 CARTON INJECTION, SOLUTION 10 28 0409-1623-21 Butorphanol Tartrate 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 28
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BUTORPHANOL TARTRATE ACTIVE INGREDIENT 2L7I72RUHN BUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 BUTORPHANOL ACTIVE MOIETY QV897JC36D BUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP BUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X BUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K BUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 WATER INACTIVE INGREDIENT 059QF0KO0R BUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-1623 BUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.] 27 Current NDC, Legacy NDC, 2 package rows 20250130_9822ca3f-aee2-46e5-8a96-495400e65d10.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 0409-1623-01 00409162301 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1623-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-1623-21) 2005-09-23 0000-00-00 No No Current 0409-1623-21 00409162321 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical