Vancomycin Hydrochloride

Product NDC: 82449-007
11-digit product format: 824490007
Labeler code: 82449
Product ID: 82449-007_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: 1.5 g/30mL
Pharmacologic classes: Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215324-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-10-02
A215324-002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-10-02
A215324-003	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-10-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A215324-001	AP
A215324-002	AP
A215324-003	AP

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 table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A215324-001	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215324-002	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215324-003	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-10-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215324-001	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215324-002	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215324-003	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-10-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215324-001	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215324-002	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215324-003	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-10-02	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215324-001	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-10-02	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215324-002	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-10-02	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215324-003	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER / INTRAVENOUS	AP	2025-10-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215324-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215324-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215324-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215324-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215324-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215324-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215324-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215324-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215324-003	AP	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215324-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215324-002	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215324-003	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Vancomycin Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VANCOMYCIN HYDROCHLORIDE	1.5 g/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
71WO621TJD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1807518	Internal RxNorm lookup
2049888	Internal RxNorm lookup
2049890	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
2c355037-6a1e-4846-872a-471ccbdc8d54	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
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 table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82449-007-02	Vancomycin Hydrochloride	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10		3
82449-007-02	Vancomycin Hydrochloride	30 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	30		3

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	XGen Pharmaceuticals DJB, Inc.	4239165c-4c15-b78e-e063-6294a90ae6af	2025-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215324 application number: ANDA215324
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	STERISCIENCE SPECIALTIES PRIVATE LIMITED	2c355037-6a1e-4846-872a-471ccbdc8d54	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215324 application number: ANDA215324 ndc (product): 82449-007

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
71WO621TJD	VANCOMYCIN HYDROCHLORIDE	1404-93-9	VANCOMYCIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
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 table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82449-007-02	82449000702	10 VIAL, SINGLE-DOSE in 1 CARTON (82449-007-02) / 30 mL in 1 VIAL, SINGLE-DOSE	2025-12-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vancomycin Hydrochloride	STERISCIENCE SPECIALTIES PRIVATE LIMITED \| Steriscience Pte. Limited \| Steriscience Sp. z o.o.	2025-10-31	HUMAN PRESCRIPTION DRUG LABEL	3