Vancomycin Hydrochloride

Product NDC: 67457-822
11-digit product format: 674570822
Labeler code: 67457
Product ID: 67457-822_74c1e534-e3d3-430d-8d58-3628160fba3a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Vancomycin Hydrochloride
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Mylan Institutional LLC
Application: NDA209481
Marketing category: NDA
Marketing start: 2018-08-31
Marketing end: 2022-02-28
Substance: VANCOMYCIN HYDROCHLORIDE
Active strength: 250 mg/5mL
Pharmacologic classes: Glycopeptide Antibacterial [EPC],Glycopeptides [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67457-822		D	Discontinued by firm		2026-10-05
excluded package	package	67457-822	67457-822-99	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67457-822-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67457-822-99	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67457-822-99	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67457-822-99	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67457-822-99	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67457-822-99	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67457-822-99	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67457-822-99	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67457-822-99	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67457-822-99	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67457-822-99	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67457-822-99	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209481-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2018-07-10
N209481-002	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10
N209481-003	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10
N209481-004	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10
N209481-005	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 1.75GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2024-06-26
N209481-006	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2024-06-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N209481-002	AP
N209481-003	AP
N209481-004	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.

Product history page 1 of 5 · 200 observed states.

Captured, Edition, Application-product table
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	N209481-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2018-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209481-002	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209481-003	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209481-004	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209481-005	VANCOMYCIN HYDROCHLORIDE	EQ 1.75GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2024-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209481-006	VANCOMYCIN HYDROCHLORIDE	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2024-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209481-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2018-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209481-002	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209481-003	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209481-004	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209481-005	VANCOMYCIN HYDROCHLORIDE	EQ 1.75GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2024-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209481-006	VANCOMYCIN HYDROCHLORIDE	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2024-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209481-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2018-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209481-002	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209481-003	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209481-004	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209481-005	VANCOMYCIN HYDROCHLORIDE	EQ 1.75GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2024-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209481-006	VANCOMYCIN HYDROCHLORIDE	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2024-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209481-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2018-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209481-002	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209481-003	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209481-004	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209481-005	VANCOMYCIN HYDROCHLORIDE	EQ 1.75GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2024-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209481-006	VANCOMYCIN HYDROCHLORIDE	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2024-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209481-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2018-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209481-002	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209481-003	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209481-004	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209481-005	VANCOMYCIN HYDROCHLORIDE	EQ 1.75GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2024-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209481-006	VANCOMYCIN HYDROCHLORIDE	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2024-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209481-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2018-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209481-002	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2018-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209481-003	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209481-004	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209481-005	VANCOMYCIN HYDROCHLORIDE	EQ 1.75GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2024-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209481-006	VANCOMYCIN HYDROCHLORIDE	EQ 2GM BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2024-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209481-001	VANCOMYCIN HYDROCHLORIDE	EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS		RLD	2018-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209481-002	VANCOMYCIN HYDROCHLORIDE	EQ 750MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2018-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209481-003	VANCOMYCIN HYDROCHLORIDE	EQ 1.25GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209481-004	VANCOMYCIN HYDROCHLORIDE	EQ 1.5GM BASE/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2018-07-10	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N209481-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209481-003	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209481-004	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209481-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209481-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209481-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209481-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209481-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209481-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209481-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209481-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209481-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209481-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209481-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209481-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209481-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209481-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209481-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209481-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209481-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209481-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209481-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209481-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209481-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209481-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209481-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209481-004	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209481-003	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209481-004	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209481-003	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209481-004	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209481-003	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209481-004	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209481-003	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209481-004	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209481-003	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209481-004	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209481-003	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209481-004	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209481-003	AP	1	`1c564ffb4f44…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
67457-822-25	Vancomycin Hydrochloride	5 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	5		12
67457-822-99	Vancomycin Hydrochloride	10 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	10		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67457-822-25	EA - Each	67457-822	6da374cc-e9eb-4b89-8d0f-5e021f751d91	1	2018-10-11
67457-822-99	EA - Each	67457-822	63e7d691-8c25-468b-961f-20a09c7a5740	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67457-822	VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]	12	Legacy NDC, 2 package rows	20240731_caf22ccb-df75-45ea-a1d0-ccb2d37272fb.zip

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	Mylan Institutional LLC	40a88420-5fcb-4715-abc5-595a18fd08d0	2024-06-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209481 application number: NDA209481
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Mylan Institutional LLC	caf22ccb-df75-45ea-a1d0-ccb2d37272fb	2024-06-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209481 application number: NDA209481 ndc (product): 67457-822

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	caf22ccb-df75-45ea-a1d0-ccb2d37272fb	12
2049890	vancomycin 1.5 GM Injection	PSN	caf22ccb-df75-45ea-a1d0-ccb2d37272fb	12
2049891	vancomycin 250 MG Injection	PSN	caf22ccb-df75-45ea-a1d0-ccb2d37272fb	12
1807518	vancomycin 750 MG Injection	PSN	caf22ccb-df75-45ea-a1d0-ccb2d37272fb	12
2049888	vancomycin 1250 MG Injection	SCD	caf22ccb-df75-45ea-a1d0-ccb2d37272fb	12
2049890	vancomycin 1500 MG Injection	SCD	caf22ccb-df75-45ea-a1d0-ccb2d37272fb	12
2049891	vancomycin 250 MG Injection	SCD	caf22ccb-df75-45ea-a1d0-ccb2d37272fb	12
1807518	vancomycin 750 MG Injection	SCD	caf22ccb-df75-45ea-a1d0-ccb2d37272fb	12
2049891	vancomycin (as vancomycin hydrochloride) 250 MG Injection	SY	caf22ccb-df75-45ea-a1d0-ccb2d37272fb	12
2049888	vancomycin 1.25 GM (as vancomycin hydrochloride 1.28 GM) Injection	SY	caf22ccb-df75-45ea-a1d0-ccb2d37272fb	12
2049888	vancomycin 1.25 GM Injection	SY	caf22ccb-df75-45ea-a1d0-ccb2d37272fb	12
2049890	vancomycin 1.5 GM (as vancomycin hydrochloride 1.54 GM) Injection	SY	caf22ccb-df75-45ea-a1d0-ccb2d37272fb	12
2049890	vancomycin 1.5 GM Injection	SY	caf22ccb-df75-45ea-a1d0-ccb2d37272fb	12
1807518	vancomycin 750 MG (as vancomycin hydrochloride 769 MG) Injection	SY	caf22ccb-df75-45ea-a1d0-ccb2d37272fb	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67457-822-25	67457082225	5 mL in 1 VIAL, SINGLE-DOSE	5 ml					Historical
67457-822-99	67457082299	10 VIAL, SINGLE-DOSE in 1 CARTON (67457-822-99) > 5 mL in 1 VIAL, SINGLE-DOSE (67457-822-25)		2018-08-31	2022-02-28	No	No	Current