Ropivacaine Hydrochloride
- Product NDC
- 0409-9302
- 11-digit product format
- 004099302
- Labeler code
- 0409
- Product ID
- 0409-9302_0669f092-f34e-40c2-af54-8004c205032d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ROPIVACAINE HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- EPIDURAL; PERINEURAL
- Labeler
- Hospira, Inc.
- Application
- ANDA090194
- Marketing category
- ANDA
- Marketing start
- 2014-09-23
- Marketing end
- 0000-00-00
- Substance
- ROPIVACAINE HYDROCHLORIDE
- Active strength
- 8 mg/mL
- Pharmacologic classes
- Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 0409-9302 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0409-9302 | 0409-9302-20 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A090194-001 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 20MG/10ML (2MG/ML) | SOLUTION / INJECTION | | | 2014-09-23 |
| A090194-002 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 150MG/30ML (5MG/ML) | SOLUTION / INJECTION | | | 2014-09-23 |
| A090194-003 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 150MG/20ML (7.5MG/ML) | SOLUTION / INJECTION | | | 2014-09-23 |
| A090194-004 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 100MG/10ML (10MG/ML) | SOLUTION / INJECTION | | | 2014-09-23 |
| A090194-005 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 40MG/20ML (2MG/ML) | SOLUTION / INJECTION | | | 2014-09-23 |
| A090194-006 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 200MG/20ML (10MG/ML) | SOLUTION / INJECTION | | | 2014-09-23 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ROPIVACAINE HYDROCHLORIDE | ACTIVE INGREDIENT | V910P86109 | ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 1 | |
| ROPIVACAINE | ACTIVE MOIETY | 7IO5LYA57N | ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ROPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 1 | |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0409-9302-20 | 00409930220 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-9302-20) > 20 mL in 1 VIAL, SINGLE-DOSE (0409-9302-21) | 2014-09-23 | 0000-00-00 | No | No | Current |