Vancomycin Hydrochloride
- Product NDC
- 83634-114
- 11-digit product format
- 836340114
- Labeler code
- 83634
- Product ID
- 83634-114_5bcdb2e4-8cba-4cea-9cc2-872ddbb105c7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vancomycin hydrochloride
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS; ORAL
- Labeler
- Avenacy, LLC
- Application
- NDA210274
- Marketing category
- NDA
- Marketing start
- 2026-08-15
- Substance
- VANCOMYCIN HYDROCHLORIDE
- Active strength
- 750 mg/1
- Pharmacologic classes
- Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
- 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 |
|---|---|---|---|---|---|---|---|
| N210274-001 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | |
| N210274-002 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | |
| N210274-003 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | |
| N210274-004 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | |
| N210274-005 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | |
| N210274-006 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | |
| N210274-007 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | EQ 1.5MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N210274-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210274-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210274-003 | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210274-004 | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210274-005 | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210274-006 | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N210274-007 | VANCOMYCIN HYDROCHLORIDE | EQ 1.5MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N210274-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210274-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210274-003 | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210274-004 | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210274-005 | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210274-006 | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N210274-007 | VANCOMYCIN HYDROCHLORIDE | EQ 1.5MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210274-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210274-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210274-003 | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210274-004 | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210274-005 | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210274-006 | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210274-007 | VANCOMYCIN HYDROCHLORIDE | EQ 1.5MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210274-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210274-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210274-003 | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210274-004 | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210274-005 | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210274-006 | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210274-007 | VANCOMYCIN HYDROCHLORIDE | EQ 1.5MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2025-08-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210274-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210274-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210274-003 | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210274-004 | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210274-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210274-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210274-003 | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210274-004 | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210274-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210274-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210274-003 | VANCOMYCIN HYDROCHLORIDE | EQ 5GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210274-004 | VANCOMYCIN HYDROCHLORIDE | EQ 10GM BASE/VIAL | POWDER / INTRAVENOUS, ORAL | RLD, RS | 2023-01-20 | b8a1b40f171c… |
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
- Vancomycin Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| VANCOMYCIN HYDROCHLORIDE | 750 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 71WO621TJD | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c757e65b-ca6f-4c00-afe2-025962b43d31 | Available on FDA.report |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Vancomycin Hydrochloride | VANCOMYCIN HYDROCHLORIDE | Avenacy, LLC | c757e65b-ca6f-4c00-afe2-025962b43d31 | 2026-07-31 | Warnings, Adverse reactions | 210274 NDA210274 83634-114 |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | HIKMA PHARMACEUTICALS USA INC. | 8eccafe8-40c9-495a-872d-7f45a98ee759 | 2025-08-13 | Warnings, Adverse reactions | 210274 NDA210274 |
| VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE | HIKMA PHARMACEUTICALS USA INC. | e4ce7b87-fab4-4b7a-b121-eba136c464ce | 2024-08-07 | Warnings, Adverse reactions | 210274 NDA210274 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 83634-114-20 | 83634011420 | 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-114-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-114-41) | 2026-08-15 | No | No | Current |