Vancomycin Hydrochloride
- Product NDC
- 82449-005
- 11-digit product format
- 824490005
- Labeler code
- 82449
- Product ID
- 82449-005_4cab32fc-cec1-71f0-e063-6394a90a35da
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vancomycin Hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- STERISCIENCE SPECIALTIES PRIVATE LIMITED
- Application
- ANDA215324
- Marketing category
- ANDA
- Marketing start
- 2025-12-15
- Substance
- VANCOMYCIN HYDROCHLORIDE
- Active strength
- 750 mg/20mL
- Pharmacologic classes
- Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Vancomycin Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| VANCOMYCIN HYDROCHLORIDE | 750 mg/20mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 71WO621TJD |
| Rxcui | 1807518, 2049888, 2049890 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 518d3e87-1791-43fd-b421-7f508923e5f1 | Product name | 4 | 20260107 |
| 8c6bdc15-c879-407f-914d-b44fce8e7bbd | Product name | 1 | 20240730 |
| 324cd4ef-8967-4991-91fd-3046d51874b9 | Product name | 2 | 20240118 |
| ba2497d8-e8e9-d71b-251e-24ac323bbaa3 | Product name | 9 | 20231206 |
| 01f96903-8ada-4a91-9a58-9f8e51b7a70a | Product name | 1 | 20230922 |
| e5c5573a-2fda-453b-9d65-c6185b588ecd | Product name | 5 | 20220613 |
| 3a86dfd0-ed28-4976-b9ec-00923fbfbdd4 | Product name | 1 | 20220308 |
| 5d603187-d384-6e74-5fc7-30310b2b3c99 | Product name | 3 | 20190717 |
| bec007f0-8cd6-4f79-a3df-c0d94ebb2a36 | Product name | 1 | 20190614 |
| f4fec0bc-aaaa-4c5c-aa2b-21daf18ef477 | Product name | 1 | 20160209 |
| a0c54c75-e1f1-eb4f-25c4-be91c2fe237d | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82449-005-02 | Vancomycin Hydrochloride | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | 3 | |
| 82449-005-02 | Vancomycin Hydrochloride | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 | 3 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2049888 | vancomycin 1.25 GM Injection | PSN | 2c355037-6a1e-4846-872a-471ccbdc8d54 | 3 |
| 2049890 | vancomycin 1.5 GM Injection | PSN | 2c355037-6a1e-4846-872a-471ccbdc8d54 | 3 |
| 1807518 | vancomycin 750 MG Injection | PSN | 2c355037-6a1e-4846-872a-471ccbdc8d54 | 3 |
| 2049888 | vancomycin 1250 MG Injection | SCD | 2c355037-6a1e-4846-872a-471ccbdc8d54 | 3 |
| 2049890 | vancomycin 1500 MG Injection | SCD | 2c355037-6a1e-4846-872a-471ccbdc8d54 | 3 |
| 1807518 | vancomycin 750 MG Injection | SCD | 2c355037-6a1e-4846-872a-471ccbdc8d54 | 3 |
| 2049888 | vancomycin 1.25 GM (as vancomycin hydrochloride 1.28 GM) Injection | SY | 2c355037-6a1e-4846-872a-471ccbdc8d54 | 3 |
| 2049888 | vancomycin 1.25 GM Injection | SY | 2c355037-6a1e-4846-872a-471ccbdc8d54 | 3 |
| 2049890 | vancomycin 1.5 GM (as vancomycin hydrochloride 1.54 GM) Injection | SY | 2c355037-6a1e-4846-872a-471ccbdc8d54 | 3 |
| 2049890 | vancomycin 1.5 GM Injection | SY | 2c355037-6a1e-4846-872a-471ccbdc8d54 | 3 |
| 1807518 | vancomycin 750 MG (as vancomycin hydrochloride 769 MG) Injection | SY | 2c355037-6a1e-4846-872a-471ccbdc8d54 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 82449-005-02 | 82449000502 | 10 VIAL, SINGLE-DOSE in 1 CARTON (82449-005-02) / 20 mL in 1 VIAL, SINGLE-DOSE | 2025-12-15 | No | No | Historical |