Butorphanol Tartrate
- Product NDC
- 0409-1623
- 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
Orange Book products#
| 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#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A074626-001 | BUTORPHANOL TARTRATE PRESERVATIVE FREE | 1MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-01-23 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A074626-002 | BUTORPHANOL TARTRATE PRESERVATIVE FREE | 2MG/ML | INJECTABLE / INJECTION | AP | RS | 1997-01-23 | c2088c7a36db… |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2021-12-28 21:50 UTC | 2021-12 | A074626-001 | AP | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A074626-002 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074626-001 | AP | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074626-002 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A074626-001 | AP | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A074626-002 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A074626-001 | AP | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A074626-002 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A074626-001 | AP | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A074626-002 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A074626-001 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A074626-002 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A074626-001 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A074626-002 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A074626-001 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A074626-002 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074626-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074626-002 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A074626-001 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A074626-002 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A074626-001 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A074626-002 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074626-001 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074626-002 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074626-001 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074626-002 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074626-001 | AP | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074626-002 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074626-001 | AP | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074626-002 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A074626-001 | AP | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A074626-002 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A074626-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A074626-002 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074626-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074626-002 | AP | 1 | 3a93d1ddd44b… |
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 |
|---|---|
| BUTORPHANOL TARTRATE | 1 mg/mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| acf6c143-7e17-30a4-779f-24d002b44752 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0409-1623-01 | ML - Milliliter | 0409-1623 | 1403abb9-f562-413e-91a4-8b1485338fa5 | 1 | 2013-02-13 |
| 0409-1623-21 | ML - Milliliter | 0409-1623 | 96f5f5e0-52ec-4c61-99f6-d4e9529cd41d | 1 | 2019-07-02 |
DailyMed Socrata Ingredients#
| 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#
DailyMed RxNorm Mappings#
| 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 | 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 |