TYZAVAN
- Product NDC
- 0143-9468
- 11-digit product format
- 001439468
- Labeler code
- 0143
- Product ID
- 0143-9468_720cb743-c9a5-46eb-aa72-2bcccff230aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Vancomycin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA211962
- Marketing category
- NDA
- Marketing start
- 2025-10-17
- Substance
- VANCOMYCIN
- Active strength
- 750 mg/150mL
- Pharmacologic classes
- Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N211962-001 | TYZAVAN | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/100ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | |
| N211962-002 | TYZAVAN | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/200ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | |
| N211962-003 | TYZAVAN | VANCOMYCIN HYDROCHLORIDE | EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | |
| N211962-004 | TYZAVAN | VANCOMYCIN HYDROCHLORIDE | EQ 2GM BASE/400ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | |
| N211962-005 | TYZAVAN | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/150ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-05-13 | |
| N211962-006 | TYZAVAN | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-05-13 | |
| N211962-007 | TYZAVAN | VANCOMYCIN HYDROCHLORIDE | EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-05-13 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N211962-001 | 10039804 | 2035-11-06 | U-282 | Drug product | 2019-03-11 |
| N211962-001 | 10188697 | 2035-11-06 | U-282 | Drug product | 2019-03-11 |
| N211962-001 | 10849956 | 2035-11-06 | Drug product | 2020-12-10 | |
| N211962-001 | 11517609 | 2035-11-06 | U-282 | 2022-12-15 | |
| N211962-001 | 11628200 | 2035-11-06 | Drug product | 2023-05-09 | |
| N211962-001 | 12161690 | 2035-11-06 | Drug product | 2025-01-10 | |
| N211962-002 | 10039804 | 2035-11-06 | U-282 | Drug product | 2019-03-11 |
| N211962-002 | 10188697 | 2035-11-06 | U-282 | Drug product | 2019-03-11 |
| N211962-002 | 10849956 | 2035-11-06 | Drug product | 2020-12-10 | |
| N211962-002 | 11517609 | 2035-11-06 | U-282 | 2022-12-15 | |
| N211962-002 | 11628200 | 2035-11-06 | Drug product | 2023-05-09 | |
| N211962-002 | 12161690 | 2035-11-06 | Drug product | 2025-01-10 | |
| N211962-003 | 10039804 | 2035-11-06 | U-282 | Drug product | 2019-03-11 |
| N211962-003 | 10188697 | 2035-11-06 | U-282 | Drug product | 2019-03-11 |
| N211962-003 | 10849956 | 2035-11-06 | Drug product | 2020-12-10 | |
| N211962-003 | 11517609 | 2035-11-06 | U-282 | 2022-12-15 | |
| N211962-003 | 11628200 | 2035-11-06 | Drug product | 2023-05-09 | |
| N211962-003 | 12161690 | 2035-11-06 | Drug product | 2025-01-10 | |
| N211962-004 | 10039804 | 2035-11-06 | U-282 | Drug product | 2019-03-11 |
| N211962-004 | 10188697 | 2035-11-06 | U-282 | Drug product | 2019-03-11 |
| N211962-004 | 10849956 | 2035-11-06 | Drug product | 2020-12-10 | |
| N211962-004 | 11517609 | 2035-11-06 | U-282 | 2022-12-15 | |
| N211962-004 | 11628200 | 2035-11-06 | Drug product | 2023-05-09 | |
| N211962-004 | 12161690 | 2035-11-06 | Drug product | 2025-01-10 | |
| N211962-005 | 10039804 | 2035-11-06 | U-282 | Drug product | 2020-05-22 |
| N211962-005 | 10188697 | 2035-11-06 | U-282 | Drug product | 2020-05-22 |
| N211962-005 | 10849956 | 2035-11-06 | Drug product | 2020-12-10 | |
| N211962-005 | 11517609 | 2035-11-06 | U-282 | 2022-12-15 | |
| N211962-005 | 11628200 | 2035-11-06 | Drug product | 2023-05-09 | |
| N211962-005 | 12161690 | 2035-11-06 | Drug product | 2025-01-10 | |
| N211962-006 | 10039804 | 2035-11-06 | U-282 | Drug product | 2020-05-22 |
| N211962-006 | 10188697 | 2035-11-06 | U-282 | Drug product | 2020-05-22 |
| N211962-006 | 10849956 | 2035-11-06 | Drug product | 2020-12-10 | |
| N211962-006 | 11517609 | 2035-11-06 | U-282 | 2022-12-15 | |
| N211962-006 | 11628200 | 2035-11-06 | Drug product | 2023-05-09 | |
| N211962-006 | 12161690 | 2035-11-06 | Drug product | 2025-01-10 | |
| N211962-007 | 10039804 | 2035-11-06 | U-282 | Drug product | 2020-05-22 |
| N211962-007 | 10188697 | 2035-11-06 | U-282 | Drug product | 2020-05-22 |
| N211962-007 | 10849956 | 2035-11-06 | Drug product | 2020-12-10 | |
| N211962-007 | 11517609 | 2035-11-06 | U-282 | 2022-12-15 | |
| N211962-007 | 11628200 | 2035-11-06 | Drug product | 2023-05-09 | |
| N211962-007 | 12161690 | 2035-11-06 | Drug product | 2025-01-10 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N211962-001 | TYZAVAN | EQ 500MG BASE/100ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-002 | TYZAVAN | EQ 1GM BASE/200ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-003 | TYZAVAN | EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-004 | TYZAVAN | EQ 2GM BASE/400ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-005 | TYZAVAN | EQ 750MG BASE/150ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-05-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-006 | TYZAVAN | EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-05-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-007 | TYZAVAN | EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-05-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N211962-001 | TYZAVAN | EQ 500MG BASE/100ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N211962-002 | TYZAVAN | EQ 1GM BASE/200ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N211962-003 | TYZAVAN | EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N211962-004 | TYZAVAN | EQ 2GM BASE/400ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N211962-005 | TYZAVAN | EQ 750MG BASE/150ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-05-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N211962-006 | TYZAVAN | EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-05-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N211962-007 | TYZAVAN | EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-05-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211962-001 | TYZAVAN | EQ 500MG BASE/100ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211962-002 | TYZAVAN | EQ 1GM BASE/200ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211962-003 | TYZAVAN | EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211962-004 | TYZAVAN | EQ 2GM BASE/400ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211962-005 | TYZAVAN | EQ 750MG BASE/150ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-05-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211962-006 | TYZAVAN | EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-05-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211962-007 | TYZAVAN | EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-05-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211962-001 | TYZAVAN | EQ 500MG BASE/100ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211962-002 | TYZAVAN | EQ 1GM BASE/200ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211962-003 | TYZAVAN | EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211962-004 | TYZAVAN | EQ 2GM BASE/400ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211962-005 | TYZAVAN | EQ 750MG BASE/150ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-05-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211962-006 | TYZAVAN | EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-05-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211962-007 | TYZAVAN | EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-05-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211962-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/100ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211962-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/200ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211962-003 | VANCOMYCIN HYDROCHLORIDE | EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211962-004 | VANCOMYCIN HYDROCHLORIDE | EQ 2GM BASE/400ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211962-005 | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/150ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-05-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211962-006 | VANCOMYCIN HYDROCHLORIDE | EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-05-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211962-007 | VANCOMYCIN HYDROCHLORIDE | EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-05-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211962-001 | VANCOMYCIN HYDROCHLORIDE | EQ 500MG BASE/100ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211962-002 | VANCOMYCIN HYDROCHLORIDE | EQ 1GM BASE/200ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211962-003 | VANCOMYCIN HYDROCHLORIDE | EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211962-004 | VANCOMYCIN HYDROCHLORIDE | EQ 2GM BASE/400ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2019-02-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211962-005 | VANCOMYCIN HYDROCHLORIDE | EQ 750MG BASE/150ML (EQ 5MG BASE/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-05-13 | b8a1b40f171c… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N211962-001 | 10039804 | 2035-11-06 | U-282 | Drug product | 2019-03-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N211962-001 | 10188697 | 2035-11-06 | U-282 | Drug product | 2019-03-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N211962-001 | 10849956 | 2035-11-06 | Drug product | 2020-12-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-001 | 11517609 | 2035-11-06 | U-282 | 2022-12-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-001 | 11628200 | 2035-11-06 | Drug product | 2023-05-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-001 | 12161690 | 2035-11-06 | Drug product | 2025-01-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-002 | 10039804 | 2035-11-06 | U-282 | Drug product | 2019-03-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N211962-002 | 10188697 | 2035-11-06 | U-282 | Drug product | 2019-03-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N211962-002 | 10849956 | 2035-11-06 | Drug product | 2020-12-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-002 | 11517609 | 2035-11-06 | U-282 | 2022-12-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-002 | 11628200 | 2035-11-06 | Drug product | 2023-05-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-002 | 12161690 | 2035-11-06 | Drug product | 2025-01-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-003 | 10039804 | 2035-11-06 | U-282 | Drug product | 2019-03-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N211962-003 | 10188697 | 2035-11-06 | U-282 | Drug product | 2019-03-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N211962-003 | 10849956 | 2035-11-06 | Drug product | 2020-12-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-003 | 11517609 | 2035-11-06 | U-282 | 2022-12-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-003 | 11628200 | 2035-11-06 | Drug product | 2023-05-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-003 | 12161690 | 2035-11-06 | Drug product | 2025-01-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-004 | 10039804 | 2035-11-06 | U-282 | Drug product | 2019-03-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N211962-004 | 10188697 | 2035-11-06 | U-282 | Drug product | 2019-03-11 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N211962-004 | 10849956 | 2035-11-06 | Drug product | 2020-12-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-004 | 11517609 | 2035-11-06 | U-282 | 2022-12-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-004 | 11628200 | 2035-11-06 | Drug product | 2023-05-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-004 | 12161690 | 2035-11-06 | Drug product | 2025-01-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-005 | 10039804 | 2035-11-06 | U-282 | Drug product | 2020-05-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N211962-005 | 10188697 | 2035-11-06 | U-282 | Drug product | 2020-05-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N211962-005 | 10849956 | 2035-11-06 | Drug product | 2020-12-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-005 | 11517609 | 2035-11-06 | U-282 | 2022-12-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-005 | 11628200 | 2035-11-06 | Drug product | 2023-05-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-005 | 12161690 | 2035-11-06 | Drug product | 2025-01-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-006 | 10039804 | 2035-11-06 | U-282 | Drug product | 2020-05-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N211962-006 | 10188697 | 2035-11-06 | U-282 | Drug product | 2020-05-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N211962-006 | 10849956 | 2035-11-06 | Drug product | 2020-12-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-006 | 11517609 | 2035-11-06 | U-282 | 2022-12-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-006 | 11628200 | 2035-11-06 | Drug product | 2023-05-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-006 | 12161690 | 2035-11-06 | Drug product | 2025-01-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-007 | 10039804 | 2035-11-06 | U-282 | Drug product | 2020-05-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N211962-007 | 10188697 | 2035-11-06 | U-282 | Drug product | 2020-05-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N211962-007 | 10849956 | 2035-11-06 | Drug product | 2020-12-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211962-007 | 11517609 | 2035-11-06 | U-282 | 2022-12-15 | caaa826d4ba7… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TYZAVAN
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| VANCOMYCIN | 750 mg/150mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6Q205EH1VU | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1807508 | Internal RxNorm lookup |
| 1807510 | Internal RxNorm lookup |
| 1807511 | Internal RxNorm lookup |
| 2118448 | Internal RxNorm lookup |
| 2118449 | Internal RxNorm lookup |
| 2387078 | Internal RxNorm lookup |
| 2387079 | Internal RxNorm lookup |
| 2725135 | Internal RxNorm lookup |
| 2727215 | Internal RxNorm lookup |
| 2727216 | Internal RxNorm lookup |
| 2727217 | Internal RxNorm lookup |
| 2727218 | Internal RxNorm lookup |
| 2727219 | Internal RxNorm lookup |
| 2727220 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | Available on FDA.report |
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 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| a0c54c75-e1f1-eb4f-25c4-be91c2fe237d | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0143-9468-01 | TYZAVAN | 150 mL in 1 BAG | INJECTION, SOLUTION | 150 | 3 | |
| 0143-9468-06 | TYZAVAN | 6 in 1 CARTON | INJECTION, SOLUTION | 6 | 3 | |
| 0143-9468-12 | TYZAVAN | 12 in 1 CARTON | INJECTION, SOLUTION | 12 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0143-9468-12 | ML - Milliliter | 0143-9468 | 9ae23999-ac11-4352-a915-ed36607ca38b | 1 | 2025-12-16 |
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 |
|---|---|---|---|---|---|---|
| TYZAVAN | VANCOMYCIN | Hikma Pharmaceuticals USA Inc. | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 2026-08-14 | Warnings, Adverse reactions | 211962 NDA211962 0143-9468 |
| Vancomycin | VANCOMYCIN | Xellia Pharmaceuticals USA LLC | 60bee69b-be70-412c-9e83-a24a0a8a5e7b | 2023-03-23 | Boxed warning, Warnings, Adverse reactions | 211962 NDA211962 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2725135 | TYZAVAN 1 GM in 200 ML Injection | PSN | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727215 | TYZAVAN 1.25 GM in 250 ML Injection | PSN | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727218 | TYZAVAN 1.5 GM in 300 ML Injection | PSN | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727216 | TYZAVAN 1.75 GM in 350 ML Injection | PSN | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727219 | TYZAVAN 2 GM in 400 ML Injection | PSN | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727220 | TYZAVAN 500 MG in 100 ML Injection | PSN | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727217 | TYZAVAN 750 MG in 150 ML Injection | PSN | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 1807508 | vancomycin 1 GM in 200 ML Injection | PSN | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2387078 | vancomycin 1.25 GM in 250 ML Injection | PSN | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2118448 | vancomycin 1.5 GM in 300 ML Injection | PSN | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2387079 | vancomycin 1.75 GM in 350 ML Injection | PSN | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2118449 | vancomycin 2 GM in 400 ML Injection | PSN | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 1807511 | vancomycin 500 MG in 100 ML Injection | PSN | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 1807510 | vancomycin 750 MG in 150 ML Injection | PSN | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727220 | 100 ML vancomycin 5 MG/ML Injection [Tyzavan] | SBD | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727217 | 150 ML vancomycin 5 MG/ML Injection [Tyzavan] | SBD | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2725135 | 200 ML vancomycin 5 MG/ML Injection [Tyzavan] | SBD | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727215 | 250 ML vancomycin 5 MG/ML Injection [Tyzavan] | SBD | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727218 | 300 ML vancomycin 5 MG/ML Injection [Tyzavan] | SBD | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727216 | 350 ML vancomycin 5 MG/ML Injection [Tyzavan] | SBD | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727219 | 400 ML vancomycin 5 MG/ML Injection [Tyzavan] | SBD | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 1807511 | 100 ML vancomycin 5 MG/ML Injection | SCD | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 1807510 | 150 ML vancomycin 5 MG/ML Injection | SCD | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 1807508 | 200 ML vancomycin 5 MG/ML Injection | SCD | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2387078 | 250 ML vancomycin 5 MG/ML Injection | SCD | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2118448 | 300 ML vancomycin 5 MG/ML Injection | SCD | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2387079 | 350 ML vancomycin 5 MG/ML Injection | SCD | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2118449 | 400 ML vancomycin 5 MG/ML Injection | SCD | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727220 | 100 ML Tyzavan 5 MG/ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727217 | 150 ML Tyzavan 5 MG/ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727215 | 250 ML Tyzavan 5 MG/ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727218 | 300 ML Tyzavan 5 MG/ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727216 | 350 ML Tyzavan 5 MG/ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727219 | 400 ML Tyzavan 5 MG/ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2725135 | Tyzavan 1 GM per 200 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727215 | Tyzavan 1.25 GM per 250 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727218 | Tyzavan 1.5 GM per 300 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727216 | Tyzavan 1.75 GM per 350 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727219 | Tyzavan 2 GM per 400 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2725135 | Tyzavan 5 MG/ML per 200 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727220 | Tyzavan 500 MG per 100 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2727217 | Tyzavan 750 MG per 150 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2118448 | vancomycin (as vancomycin HCl) 1.5 GM per 300 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2118449 | vancomycin (as vancomycin HCl) 2 GM per 400 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 1807511 | vancomycin (as vancomycin HCl) 500 MG per 100 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 1807508 | vancomycin (as vancomycin hydrochloride) 1 GM per 200 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 1807510 | vancomycin (as vancomycin hydrochloride) 750 MG per 150 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 1807508 | vancomycin 1 GM per 200 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2387078 | vancomycin 1.25 GM per 250 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2118448 | vancomycin 1.5 GM per 300 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2387079 | vancomycin 1.75 GM per 350 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2387078 | vancomycin 1250 MG per 250 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2387079 | vancomycin 1750 MG per 350 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 2118449 | vancomycin 2 GM per 400 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 1807511 | vancomycin 500 MG per 100 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
| 1807510 | vancomycin 750 MG per 150 ML Injection | SY | 72e9c5e2-07cc-4a8b-ba64-b2e7619ea560 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0143-9468-01 | 00143946801 | 150 mL in 1 BAG | 150 ml | Historical | |||
| 0143-9468-06 | 00143946806 | 6 BAG in 1 CARTON (0143-9468-06) / 150 mL in 1 BAG (0143-9468-01) | 6 bag | 2025-10-17 | No | No | Current |
| 0143-9468-12 | 00143946812 | 12 BAG in 1 CARTON (0143-9468-12) / 150 mL in 1 BAG (0143-9468-01) | 12 bag | 2025-10-17 | No | No | Current |