Home NDC 0409-1623-01 Butorphanol Tartrate
Product NDC 0409-1623
Requested package NDC 0409-1623-01
11-digit product format 004091623
Labeler code 0409
Product ID 0409-1623_f9eb40ee-3daa-423d-ac1f-be76b7f267e2
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 43 .
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 · 86 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 2026-09-14 22:38:34 2026-08 A074626-001 BUTORPHANOL TARTRATE PRESERVATIVE FREE 1MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A074626-002 BUTORPHANOL TARTRATE PRESERVATIVE FREE 2MG/ML INJECTABLE / INJECTION AP RS 1997-01-23 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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 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