Bupivacaine
- Product NDC
- 0409-3613
- 11-digit product format
- 004093613
- Labeler code
- 0409
- Product ID
- 0409-3613_7a09a90d-26da-42bd-bb54-2d2102eb8c1c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUPIVACAINE HYDROCHLORIDE IN DEXTROSE
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBARACHNOID
- Labeler
- Hospira, Inc.
- Application
- ANDA071810
- Marketing category
- ANDA
- Marketing start
- 2005-01-31
- Substance
- BUPIVACAINE HYDROCHLORIDE
- Active strength
- 7.5 mg/mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bupivacaine
- Brand name suffix
- Spinal
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUPIVACAINE HYDROCHLORIDE | 7.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7TQO7W3VT8 |
| Rxcui | 1724784 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-3613-01 | BupivacaineSpinal | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 29 |
| 0409-3613-11 | BupivacaineSpinal | 2 mL in 1 AMPULE | INJECTION, SOLUTION | 2 | | 29 |
| 0409-3613-01 | General Surgery Kit | 2 mL in 1 AMPULE | INJECTION, SOLUTION | 2 mL | 7.5 mg in 1mL | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BUPIVACAINE HYDROCHLORIDE | ACTIVE INGREDIENT | 7TQO7W3VT8 | BUPIVACAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| BUPIVACAINE | ACTIVE MOIETY | Y8335394RO | BUPIVACAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| ANHYDROUS DEXTROSE | INACTIVE INGREDIENT | 5SL0G7R0OK | BUPIVACAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | BUPIVACAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | BUPIVACAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.] | 15 | |
| BUPIVACAINE HYDROCHLORIDE | ACTIVE INGREDIENT | 7TQO7W3VT8 | GENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS] | 1 | |
| BUPIVACAINE | ACTIVE MOIETY | Y8335394RO | GENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS] | 1 | |
| ANHYDROUS DEXTROSE | INACTIVE INGREDIENT | 5SL0G7R0OK | GENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | GENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | GENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-3613 | BUPIVACAINE SPINAL (BUPIVACAINE HYDROCHLORIDE IN DEXTROSE) INJECTION, SOLUTION [HOSPIRA, INC.] | 28 | Current NDC, Legacy NDC, 2 package rows | 20241027_7a8d2539-4422-4312-0298-207ef1a2948e.zip |
| 0409-3613 | GENERAL SURGERY KIT () KIT [CENTURION MEDICAL PRODUCTS] | 1 | Current NDC, Legacy NDC | 20120925_493569d1-291b-4d89-aa0f-17474d90aa09.zip |
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 |
|---|
| 0409-3613-01 | 00409361301 | 10 AMPULE in 1 CARTON (0409-3613-01) / 2 mL in 1 AMPULE (0409-3613-11) | 10 ampule | 2005-01-31 | 0000-00-00 | No | No | Current |
| 0409-3613-11 | 00409361311 | 2 mL in 1 AMPULE | 2 ml | | | | | Historical |