Application 062911

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062911-001	VANCOMYCIN HYDROCHLORIDE	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062911-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062911-001	VANCOMYCIN HYDROCHLORIDE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	AP	RS	1988-08-04	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062911-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062911-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062911-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062911-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062911-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062911-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062911-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062911-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062911-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062911-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062911-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062911-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062911-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062911-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062911-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062911-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062911-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062911-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062911-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062911-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062911-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062911-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062911-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062911-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062911-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062911-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062911-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062911-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062911-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062911-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062911-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062911-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062911-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062911-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062911-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062911-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062911-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062911-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062911-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062911-001	AP	1	`cb3db0bc1861…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hospira, Inc.	f2901045-904f-47bd-74a1-c561facd7f25	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062911 application number: ANDA062911 ndc (product): 0409-4332
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hospira, Inc.	c9ea31ec-4c26-452f-b07b-c5f894212cd5	2026-04-01	Warnings, Adverse reactions	Exact identifier ndc (product): 0409-4332
Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Henry Schein, Inc.	1bda7fa4-fdee-410a-a216-02cfbf91632f	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062911 application number: ANDA062911 ndc (product): 0404-9965

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9965	Vancomycin Hydrochloride	Vancomycin Hydrochloride	Henry Schein, Inc.	ANDA	Current
0409-4332	Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4332	Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4332	Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4332	Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4332	Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4332	Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4332	Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4332	Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4332	Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4332	Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4332	Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4332	Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4332	Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
0409-4332	Vancomycin Hydrochloride	VANCOMYCIN HYDROCHLORIDE	Hospira, Inc.	ANDA	Current
52584-332	Vancomycin Hydrochloride	Vancomycin Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-332	Vancomycin Hydrochloride	Vancomycin Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-332	Vancomycin Hydrochloride	Vancomycin Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-332	Vancomycin Hydrochloride	Vancomycin Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current
52584-332	Vancomycin Hydrochloride	Vancomycin Hydrochloride	General Injectables & Vaccines, Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39399	SUPPL	2012-07-30