Butorphanol Tartrate

Product NDC: 0409-1626
Requested package NDC: 0409-1626-10
11-digit product format: 004091626
Labeler code: 0409
Product ID: 0409-1626_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: 2005-12-20
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0409-1626	0409-1626-10	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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.

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

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074626-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074626-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074626-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074626-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074626-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074626-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074626-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074626-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074626-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074626-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074626-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074626-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074626-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074626-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074626-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074626-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074626-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074626-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074626-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074626-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074626-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074626-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074626-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074626-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074626-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074626-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074626-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074626-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074626-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074626-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074626-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074626-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074626-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074626-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074626-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074626-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074626-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074626-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074626-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074626-002	AP	1	`bb7c543d1eb4…`

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	2 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9822ca3f-aee2-46e5-8a96-495400e65d10	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
acf6c143-7e17-30a4-779f-24d002b44752	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0409-1626-01	Butorphanol Tartrate	10 in 1 CARTON	INJECTION, SOLUTION	10	28
0409-1626-02	Butorphanol Tartrate	10 in 1 CARTON	INJECTION, SOLUTION	10	28
0409-1626-21	Butorphanol Tartrate	1 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	1	28
0409-1626-42	Butorphanol Tartrate	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	2	28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-1626-01	ML - Milliliter	0409-1626	a8e4998f-6a50-499b-bd30-4474e8c7e5a3	1	2013-02-13
0409-1626-02	ML - Milliliter	0409-1626	dfd97f1e-ea5e-487e-ad2f-8ae3d2f5eed7	1	2013-02-13
0409-1626-09	ML - Milliliter	0409-1626	e760f1c4-13c6-4c2e-9596-dacf7480b1cb	1	2016-03-04
0409-1626-10	ML - Milliliter	0409-1626	259aa9b3-4289-433e-9c94-eaca7fbda42a	1	2016-03-04
0409-1626-21	ML - Milliliter	0409-1626	13f725f7-911b-487e-a071-61e6b1f37eb7	1	2019-07-02
0409-1626-42	ML - Milliliter	0409-1626	a6ee5047-8551-4e72-a3c3-a19401a2a0af	1	2019-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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
0409-1626	BUTORPHANOL TARTRATE INJECTION, SOLUTION [HOSPIRA, INC.]	27	Current NDC, Legacy NDC, 4 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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Butorphanol Tartrate	BUTORPHANOL TARTRATE	Hospira, Inc.	9822ca3f-aee2-46e5-8a96-495400e65d10	2026-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074626 application number: ANDA074626 ndc (product): 0409-1626

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2L7I72RUHN	BUTORPHANOL TARTRATE	58786-99-5	BUTORPHANOL TARTRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
886627	butorphanol tartrate 1 MG in 1 ML Injection	PSN	9822ca3f-aee2-46e5-8a96-495400e65d10	28
1728351	butorphanol tartrate 2 MG in 1 ML Injection	PSN	9822ca3f-aee2-46e5-8a96-495400e65d10	28
1728355	butorphanol tartrate 4 MG in 2 ML Injection	PSN	9822ca3f-aee2-46e5-8a96-495400e65d10	28
886627	1 ML butorphanol tartrate 1 MG/ML Injection	SCD	9822ca3f-aee2-46e5-8a96-495400e65d10	28
1728351	1 ML butorphanol tartrate 2 MG/ML Injection	SCD	9822ca3f-aee2-46e5-8a96-495400e65d10	28
1728355	2 ML butorphanol tartrate 2 MG/ML Injection	SCD	9822ca3f-aee2-46e5-8a96-495400e65d10	28
886627	butorphanol tartrate 1 MG per 1 ML Injection	SY	9822ca3f-aee2-46e5-8a96-495400e65d10	28
1728351	butorphanol tartrate 2 MG per 1 ML Injection	SY	9822ca3f-aee2-46e5-8a96-495400e65d10	28
1728355	butorphanol tartrate 4 MG per 2 ML Injection	SY	9822ca3f-aee2-46e5-8a96-495400e65d10	28

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-1626-10	00409162610	10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1626-10) > 1 mL in 1 VIAL, SINGLE-DOSE (0409-1626-09)	2016-02-11	2021-04-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Butorphanol Tartrate Injection, USP CIV	Hospira, Inc.	2026-01-02	HUMAN PRESCRIPTION DRUG LABEL	28
Butorphanol Tartrate Injection, USP CIV	Hospira, Inc.	2020-11-17	HUMAN PRESCRIPTION DRUG LABEL	8