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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N211962-001TYZAVANVANCOMYCIN HYDROCHLORIDEEQ 500MG BASE/100ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-15
N211962-002TYZAVANVANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/200ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-15
N211962-003TYZAVANVANCOMYCIN HYDROCHLORIDEEQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-15
N211962-004TYZAVANVANCOMYCIN HYDROCHLORIDEEQ 2GM BASE/400ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-15
N211962-005TYZAVANVANCOMYCIN HYDROCHLORIDEEQ 750MG BASE/150ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2020-05-13
N211962-006TYZAVANVANCOMYCIN HYDROCHLORIDEEQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2020-05-13
N211962-007TYZAVANVANCOMYCIN HYDROCHLORIDEEQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2020-05-13

Orange Book patents#

Current patent rows page 1 of 1 · 42 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N211962-001100398042035-11-06U-282Drug product2019-03-11
N211962-001101886972035-11-06U-282Drug product2019-03-11
N211962-001108499562035-11-06Drug product2020-12-10
N211962-001115176092035-11-06U-2822022-12-15
N211962-001116282002035-11-06Drug product2023-05-09
N211962-001121616902035-11-06Drug product2025-01-10
N211962-002100398042035-11-06U-282Drug product2019-03-11
N211962-002101886972035-11-06U-282Drug product2019-03-11
N211962-002108499562035-11-06Drug product2020-12-10
N211962-002115176092035-11-06U-2822022-12-15
N211962-002116282002035-11-06Drug product2023-05-09
N211962-002121616902035-11-06Drug product2025-01-10
N211962-003100398042035-11-06U-282Drug product2019-03-11
N211962-003101886972035-11-06U-282Drug product2019-03-11
N211962-003108499562035-11-06Drug product2020-12-10
N211962-003115176092035-11-06U-2822022-12-15
N211962-003116282002035-11-06Drug product2023-05-09
N211962-003121616902035-11-06Drug product2025-01-10
N211962-004100398042035-11-06U-282Drug product2019-03-11
N211962-004101886972035-11-06U-282Drug product2019-03-11
N211962-004108499562035-11-06Drug product2020-12-10
N211962-004115176092035-11-06U-2822022-12-15
N211962-004116282002035-11-06Drug product2023-05-09
N211962-004121616902035-11-06Drug product2025-01-10
N211962-005100398042035-11-06U-282Drug product2020-05-22
N211962-005101886972035-11-06U-282Drug product2020-05-22
N211962-005108499562035-11-06Drug product2020-12-10
N211962-005115176092035-11-06U-2822022-12-15
N211962-005116282002035-11-06Drug product2023-05-09
N211962-005121616902035-11-06Drug product2025-01-10
N211962-006100398042035-11-06U-282Drug product2020-05-22
N211962-006101886972035-11-06U-282Drug product2020-05-22
N211962-006108499562035-11-06Drug product2020-12-10
N211962-006115176092035-11-06U-2822022-12-15
N211962-006116282002035-11-06Drug product2023-05-09
N211962-006121616902035-11-06Drug product2025-01-10
N211962-007100398042035-11-06U-282Drug product2020-05-22
N211962-007101886972035-11-06U-282Drug product2020-05-22
N211962-007108499562035-11-06Drug product2020-12-10
N211962-007115176092035-11-06U-2822022-12-15
N211962-007116282002035-11-06Drug product2023-05-09
N211962-007121616902035-11-06Drug product2025-01-10

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.

Product history page 1 of 8 · 282 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N211962-001TYZAVANEQ 500MG BASE/100ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-15caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-002TYZAVANEQ 1GM BASE/200ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-15caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-003TYZAVANEQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-15caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-004TYZAVANEQ 2GM BASE/400ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-15caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-005TYZAVANEQ 750MG BASE/150ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2020-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-006TYZAVANEQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2020-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-007TYZAVANEQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2020-05-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N211962-001TYZAVANEQ 500MG BASE/100ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211962-002TYZAVANEQ 1GM BASE/200ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211962-003TYZAVANEQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211962-004TYZAVANEQ 2GM BASE/400ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211962-005TYZAVANEQ 750MG BASE/150ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2020-05-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211962-006TYZAVANEQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2020-05-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N211962-007TYZAVANEQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2020-05-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211962-001TYZAVANEQ 500MG BASE/100ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211962-002TYZAVANEQ 1GM BASE/200ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211962-003TYZAVANEQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211962-004TYZAVANEQ 2GM BASE/400ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211962-005TYZAVANEQ 750MG BASE/150ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2020-05-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211962-006TYZAVANEQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2020-05-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211962-007TYZAVANEQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2020-05-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N211962-001TYZAVANEQ 500MG BASE/100ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211962-002TYZAVANEQ 1GM BASE/200ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211962-003TYZAVANEQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211962-004TYZAVANEQ 2GM BASE/400ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211962-005TYZAVANEQ 750MG BASE/150ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2020-05-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211962-006TYZAVANEQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2020-05-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N211962-007TYZAVANEQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2020-05-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211962-001VANCOMYCIN HYDROCHLORIDEEQ 500MG BASE/100ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211962-002VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/200ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211962-003VANCOMYCIN HYDROCHLORIDEEQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211962-004VANCOMYCIN HYDROCHLORIDEEQ 2GM BASE/400ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211962-005VANCOMYCIN HYDROCHLORIDEEQ 750MG BASE/150ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2020-05-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211962-006VANCOMYCIN HYDROCHLORIDEEQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2020-05-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N211962-007VANCOMYCIN HYDROCHLORIDEEQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2020-05-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211962-001VANCOMYCIN HYDROCHLORIDEEQ 500MG BASE/100ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211962-002VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/200ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211962-003VANCOMYCIN HYDROCHLORIDEEQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211962-004VANCOMYCIN HYDROCHLORIDEEQ 2GM BASE/400ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2019-02-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N211962-005VANCOMYCIN HYDROCHLORIDEEQ 750MG BASE/150ML (EQ 5MG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2020-05-13b8a1b40f171c…

Observed Orange Book patent history#

Patent history page 1 of 31 · 1,201 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N211962-001100398042035-11-06U-282Drug product2019-03-11caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-001101886972035-11-06U-282Drug product2019-03-11caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-001108499562035-11-06Drug product2020-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-001115176092035-11-06U-2822022-12-15caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-001116282002035-11-06Drug product2023-05-09caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-001121616902035-11-06Drug product2025-01-10caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-002100398042035-11-06U-282Drug product2019-03-11caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-002101886972035-11-06U-282Drug product2019-03-11caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-002108499562035-11-06Drug product2020-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-002115176092035-11-06U-2822022-12-15caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-002116282002035-11-06Drug product2023-05-09caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-002121616902035-11-06Drug product2025-01-10caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-003100398042035-11-06U-282Drug product2019-03-11caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-003101886972035-11-06U-282Drug product2019-03-11caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-003108499562035-11-06Drug product2020-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-003115176092035-11-06U-2822022-12-15caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-003116282002035-11-06Drug product2023-05-09caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-003121616902035-11-06Drug product2025-01-10caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-004100398042035-11-06U-282Drug product2019-03-11caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-004101886972035-11-06U-282Drug product2019-03-11caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-004108499562035-11-06Drug product2020-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-004115176092035-11-06U-2822022-12-15caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-004116282002035-11-06Drug product2023-05-09caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-004121616902035-11-06Drug product2025-01-10caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-005100398042035-11-06U-282Drug product2020-05-22caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-005101886972035-11-06U-282Drug product2020-05-22caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-005108499562035-11-06Drug product2020-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-005115176092035-11-06U-2822022-12-15caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-005116282002035-11-06Drug product2023-05-09caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-005121616902035-11-06Drug product2025-01-10caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-006100398042035-11-06U-282Drug product2020-05-22caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-006101886972035-11-06U-282Drug product2020-05-22caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-006108499562035-11-06Drug product2020-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-006115176092035-11-06U-2822022-12-15caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-006116282002035-11-06Drug product2023-05-09caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-006121616902035-11-06Drug product2025-01-10caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-007100398042035-11-06U-282Drug product2020-05-22caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-007101886972035-11-06U-282Drug product2020-05-22caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-007108499562035-11-06Drug product2020-12-10caaa826d4ba7…
2026-08-18 06:07:402026-07N211962-007115176092035-11-06U-2822022-12-15caaa826d4ba7…

Additional Listing Data#

Finished product
Yes
Brand name base
TYZAVAN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VANCOMYCIN750 mg/150mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6Q205EH1VUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1807508Internal RxNorm lookup
1807510Internal RxNorm lookup
1807511Internal RxNorm lookup
2118448Internal RxNorm lookup
2118449Internal RxNorm lookup
2387078Internal RxNorm lookup
2387079Internal RxNorm lookup
2725135Internal RxNorm lookup
2727215Internal RxNorm lookup
2727216Internal RxNorm lookup
2727217Internal RxNorm lookup
2727218Internal RxNorm lookup
2727219Internal RxNorm lookup
2727220Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
72e9c5e2-07cc-4a8b-ba64-b2e7619ea560Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
518d3e87-1791-43fd-b421-7f508923e5f1Product name420260107
8c6bdc15-c879-407f-914d-b44fce8e7bbdProduct name120240730
324cd4ef-8967-4991-91fd-3046d51874b9Product name220240118
ba2497d8-e8e9-d71b-251e-24ac323bbaa3Product name920231206
01f96903-8ada-4a91-9a58-9f8e51b7a70aProduct name120230922
e5c5573a-2fda-453b-9d65-c6185b588ecdProduct name520220613
3a86dfd0-ed28-4976-b9ec-00923fbfbdd4Product name120220308
5d603187-d384-6e74-5fc7-30310b2b3c99Product name320190717
bec007f0-8cd6-4f79-a3df-c0d94ebb2a36Product name120190614
f4fec0bc-aaaa-4c5c-aa2b-21daf18ef477Product name120160209
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
a0c54c75-e1f1-eb4f-25c4-be91c2fe237dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9468-01TYZAVAN150 mL in 1 BAGINJECTION, SOLUTION1503
0143-9468-06TYZAVAN6 in 1 CARTONINJECTION, SOLUTION63
0143-9468-12TYZAVAN12 in 1 CARTONINJECTION, SOLUTION123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9468-12ML - Milliliter0143-94689ae23999-ac11-4352-a915-ed36607ca38b12025-12-16

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TYZAVANVANCOMYCINHikma Pharmaceuticals USA Inc.72e9c5e2-07cc-4a8b-ba64-b2e7619ea5602026-08-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 211962
application number: NDA211962
ndc (product): 0143-9468
VancomycinVANCOMYCINXellia Pharmaceuticals USA LLC60bee69b-be70-412c-9e83-a24a0a8a5e7b2023-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 211962
application number: NDA211962

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2725135TYZAVAN 1 GM in 200 ML InjectionPSN72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727215TYZAVAN 1.25 GM in 250 ML InjectionPSN72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727218TYZAVAN 1.5 GM in 300 ML InjectionPSN72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727216TYZAVAN 1.75 GM in 350 ML InjectionPSN72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727219TYZAVAN 2 GM in 400 ML InjectionPSN72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727220TYZAVAN 500 MG in 100 ML InjectionPSN72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727217TYZAVAN 750 MG in 150 ML InjectionPSN72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
1807508vancomycin 1 GM in 200 ML InjectionPSN72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2387078vancomycin 1.25 GM in 250 ML InjectionPSN72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2118448vancomycin 1.5 GM in 300 ML InjectionPSN72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2387079vancomycin 1.75 GM in 350 ML InjectionPSN72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2118449vancomycin 2 GM in 400 ML InjectionPSN72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
1807511vancomycin 500 MG in 100 ML InjectionPSN72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
1807510vancomycin 750 MG in 150 ML InjectionPSN72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727220100 ML vancomycin 5 MG/ML Injection [Tyzavan]SBD72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727217150 ML vancomycin 5 MG/ML Injection [Tyzavan]SBD72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2725135200 ML vancomycin 5 MG/ML Injection [Tyzavan]SBD72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727215250 ML vancomycin 5 MG/ML Injection [Tyzavan]SBD72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727218300 ML vancomycin 5 MG/ML Injection [Tyzavan]SBD72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727216350 ML vancomycin 5 MG/ML Injection [Tyzavan]SBD72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727219400 ML vancomycin 5 MG/ML Injection [Tyzavan]SBD72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
1807511100 ML vancomycin 5 MG/ML InjectionSCD72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
1807510150 ML vancomycin 5 MG/ML InjectionSCD72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
1807508200 ML vancomycin 5 MG/ML InjectionSCD72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2387078250 ML vancomycin 5 MG/ML InjectionSCD72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2118448300 ML vancomycin 5 MG/ML InjectionSCD72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2387079350 ML vancomycin 5 MG/ML InjectionSCD72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2118449400 ML vancomycin 5 MG/ML InjectionSCD72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727220100 ML Tyzavan 5 MG/ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727217150 ML Tyzavan 5 MG/ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727215250 ML Tyzavan 5 MG/ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727218300 ML Tyzavan 5 MG/ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727216350 ML Tyzavan 5 MG/ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727219400 ML Tyzavan 5 MG/ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2725135Tyzavan 1 GM per 200 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727215Tyzavan 1.25 GM per 250 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727218Tyzavan 1.5 GM per 300 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727216Tyzavan 1.75 GM per 350 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727219Tyzavan 2 GM per 400 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2725135Tyzavan 5 MG/ML per 200 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727220Tyzavan 500 MG per 100 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2727217Tyzavan 750 MG per 150 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2118448vancomycin (as vancomycin HCl) 1.5 GM per 300 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2118449vancomycin (as vancomycin HCl) 2 GM per 400 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
1807511vancomycin (as vancomycin HCl) 500 MG per 100 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
1807508vancomycin (as vancomycin hydrochloride) 1 GM per 200 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
1807510vancomycin (as vancomycin hydrochloride) 750 MG per 150 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
1807508vancomycin 1 GM per 200 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2387078vancomycin 1.25 GM per 250 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2118448vancomycin 1.5 GM per 300 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2387079vancomycin 1.75 GM per 350 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2387078vancomycin 1250 MG per 250 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2387079vancomycin 1750 MG per 350 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
2118449vancomycin 2 GM per 400 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
1807511vancomycin 500 MG per 100 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603
1807510vancomycin 750 MG per 150 ML InjectionSY72e9c5e2-07cc-4a8b-ba64-b2e7619ea5603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0143-9468-0100143946801150 mL in 1 BAG150 mlHistorical
0143-9468-06001439468066 BAG in 1 CARTON (0143-9468-06) / 150 mL in 1 BAG (0143-9468-01) 6 bag2025-10-17NoNoCurrent
0143-9468-120014394681212 BAG in 1 CARTON (0143-9468-12) / 150 mL in 1 BAG (0143-9468-01) 12 bag2025-10-17NoNoCurrent