BUPIVACAINE HYDROCHLORIDE
- Product NDC
- 31722-277
- 11-digit product format
- 317220277
- Labeler code
- 31722
- Product ID
- 31722-277_4ea16f8e-77de-3ba7-e063-6394a90a5667
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BUPIVACAINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; RETROBULBAR
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA217821
- Marketing category
- ANDA
- Marketing start
- 2024-03-27
- 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 HYDROCHLORIDE
- 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 | 1724786, 1724787, 1724880, 1724884, 1725078, 1725082 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-277-10 | BUPIVACAINE HYDROCHLORIDE | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 3 |
| 31722-277-30 | BUPIVACAINE HYDROCHLORIDE | 30 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 30 | | 3 |
| 31722-277-31 | BUPIVACAINE HYDROCHLORIDE | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 3 |
| 31722-277-32 | BUPIVACAINE HYDROCHLORIDE | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 3 |
| 31722-277-33 | BUPIVACAINE HYDROCHLORIDE | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 3 |
| 31722-277-34 | BUPIVACAINE HYDROCHLORIDE | 25 in 1 CARTON | INJECTION, SOLUTION | 25 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-277 | BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [CAMBER PHARMACEUTICALS, INC.] | 2 | Current NDC, 6 package rows | 20250112_0e552e3a-cf52-4d74-9381-6cc1b29b4c90.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 31722-277-10 | 31722027710 | 10 mL in 1 VIAL, SINGLE-DOSE | 10 ml | | | | Historical |
| 31722-277-30 | 31722027730 | 30 mL in 1 VIAL, SINGLE-DOSE | 30 ml | | | | Historical |
| 31722-277-31 | 31722027731 | 10 VIAL, SINGLE-DOSE in 1 CARTON (31722-277-31) / 10 mL in 1 VIAL, SINGLE-DOSE (31722-277-10) | | 2024-03-27 | No | No | Current |
| 31722-277-32 | 31722027732 | 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-277-32) / 10 mL in 1 VIAL, SINGLE-DOSE (31722-277-10) | | 2024-03-27 | No | No | Current |
| 31722-277-33 | 31722027733 | 10 VIAL, SINGLE-DOSE in 1 CARTON (31722-277-33) / 30 mL in 1 VIAL, SINGLE-DOSE (31722-277-30) | | 2024-03-27 | No | No | Current |
| 31722-277-34 | 31722027734 | 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-277-34) / 30 mL in 1 VIAL, SINGLE-DOSE (31722-277-30) | | 2024-03-27 | No | No | Current |