Butorphanol Tartrate

Product NDC
0409-1626
Requested package NDC
0409-1626-01
11-digit product format
004091626
Labeler code
0409
Product ID
0409-1626_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
2005-12-20
Substance
BUTORPHANOL TARTRATE
Active strength
2 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREEBUTORPHANOL TARTRATE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-23
A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREEBUTORPHANOL TARTRATE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A074626-001AP
A074626-002AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-2384e616aacf4f…
2026-09-14 22:38:342026-08A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-2384e616aacf4f…
2026-08-18 06:07:402026-07A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-23caaa826d4ba7…
2026-08-18 06:07:402026-07A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074626-001BUTORPHANOL TARTRATE PRESERVATIVE FREE1MG/MLINJECTABLE / INJECTIONAPRS1997-01-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074626-002BUTORPHANOL TARTRATE PRESERVATIVE FREE2MG/MLINJECTABLE / INJECTIONAPRS1997-01-2374a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A074626-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A074626-002AP184e616aacf4f…
2026-08-18 06:07:402026-07A074626-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A074626-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074626-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074626-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074626-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074626-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074626-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074626-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074626-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074626-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074626-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074626-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074626-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074626-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074626-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074626-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074626-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074626-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074626-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074626-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074626-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074626-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074626-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074626-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074626-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074626-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074626-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074626-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074626-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074626-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074626-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074626-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074626-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074626-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074626-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074626-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074626-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074626-002AP174a2ff9319b5…

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
IngredientStrength
BUTORPHANOL TARTRATE2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2L7I72RUHNInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
886627Internal RxNorm lookup
1728351Internal RxNorm lookup
1728355Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9822ca3f-aee2-46e5-8a96-495400e65d10Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
acf6c143-7e17-30a4-779f-24d002b44752Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-1626-01Butorphanol Tartrate10 in 1 CARTONINJECTION, SOLUTION1028
0409-1626-02Butorphanol Tartrate10 in 1 CARTONINJECTION, SOLUTION1028
0409-1626-21Butorphanol Tartrate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION128
0409-1626-42Butorphanol Tartrate2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION228

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-1626-01ML - Milliliter0409-1626a8e4998f-6a50-499b-bd30-4474e8c7e5a312013-02-13
0409-1626-02ML - Milliliter0409-1626dfd97f1e-ea5e-487e-ad2f-8ae3d2f5eed712013-02-13
0409-1626-09ML - Milliliter0409-1626e760f1c4-13c6-4c2e-9596-dacf7480b1cb12016-03-04
0409-1626-10ML - Milliliter0409-1626259aa9b3-4289-433e-9c94-eaca7fbda42a12016-03-04
0409-1626-21ML - Milliliter0409-162613f725f7-911b-487e-a071-61e6b1f37eb712019-07-02
0409-1626-42ML - Milliliter0409-1626a6ee5047-8551-4e72-a3c3-a19401a2a0af12019-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUTORPHANOL TARTRATEACTIVE INGREDIENT2L7I72RUHNBUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.]11
BUTORPHANOLACTIVE MOIETYQV897JC36DBUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.]11
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.]11
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.]11
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KBUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.]11
WATERINACTIVE INGREDIENT059QF0KO0RBUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-1626BUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.]27Current NDC, Legacy NDC, 4 package rows20250130_9822ca3f-aee2-46e5-8a96-495400e65d10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
886627butorphanol tartrate 1 MG in 1 ML InjectionPSN9822ca3f-aee2-46e5-8a96-495400e65d1028
1728351butorphanol tartrate 2 MG in 1 ML InjectionPSN9822ca3f-aee2-46e5-8a96-495400e65d1028
1728355butorphanol tartrate 4 MG in 2 ML InjectionPSN9822ca3f-aee2-46e5-8a96-495400e65d1028
8866271 ML butorphanol tartrate 1 MG/ML InjectionSCD9822ca3f-aee2-46e5-8a96-495400e65d1028
17283511 ML butorphanol tartrate 2 MG/ML InjectionSCD9822ca3f-aee2-46e5-8a96-495400e65d1028
17283552 ML butorphanol tartrate 2 MG/ML InjectionSCD9822ca3f-aee2-46e5-8a96-495400e65d1028
886627butorphanol tartrate 1 MG per 1 ML InjectionSY9822ca3f-aee2-46e5-8a96-495400e65d1028
1728351butorphanol tartrate 2 MG per 1 ML InjectionSY9822ca3f-aee2-46e5-8a96-495400e65d1028
1728355butorphanol tartrate 4 MG per 2 ML InjectionSY9822ca3f-aee2-46e5-8a96-495400e65d1028

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-1626-010040916260110 VIAL, SINGLE-DOSE in 1 CARTON (0409-1626-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-1626-21) 2006-03-170000-00-00NoNoCurrent