Application 062912

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoYes
002VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 750MG BASE/VIALNoYes
003VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1.5GM BASE/VIALNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062912-001VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS1988-08-04
A062912-002VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEEQ 750MG BASE/VIALINJECTABLE / INJECTIONAP2009-01-07
A062912-003VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEEQ 1.5GM BASE/VIALINJECTABLE / INJECTIONRS2020-07-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A062912-001AP
A062912-002AP

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 3 · 119 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A062912-001VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS1988-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062912-002VANCOMYCIN HYDROCHLORIDEEQ 750MG BASE/VIALINJECTABLE / INJECTIONAP2009-01-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062912-003VANCOMYCIN HYDROCHLORIDEEQ 1.5GM BASE/VIALINJECTABLE / INJECTIONRS2020-07-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062912-001VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS1988-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062912-002VANCOMYCIN HYDROCHLORIDEEQ 750MG BASE/VIALINJECTABLE / INJECTIONAP2009-01-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062912-003VANCOMYCIN HYDROCHLORIDEEQ 1.5GM BASE/VIALINJECTABLE / INJECTIONRS2020-07-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A062912-001VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS1988-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062912-002VANCOMYCIN HYDROCHLORIDEEQ 750MG BASE/VIALINJECTABLE / INJECTIONAP2009-01-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062912-003VANCOMYCIN HYDROCHLORIDEEQ 1.5GM BASE/VIALINJECTABLE / INJECTIONRS2020-07-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062912-001VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS1988-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062912-002VANCOMYCIN HYDROCHLORIDEEQ 750MG BASE/VIALINJECTABLE / INJECTIONAP2009-01-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062912-003VANCOMYCIN HYDROCHLORIDEEQ 1.5GM BASE/VIALINJECTABLE / INJECTIONRS2020-07-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062912-001VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS1988-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062912-002VANCOMYCIN HYDROCHLORIDEEQ 750MG BASE/VIALINJECTABLE / INJECTIONAP2009-01-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062912-003VANCOMYCIN HYDROCHLORIDEEQ 1.5GM BASE/VIALINJECTABLE / INJECTIONRS2020-07-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062912-001VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS1988-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062912-002VANCOMYCIN HYDROCHLORIDEEQ 750MG BASE/VIALINJECTABLE / INJECTIONAP2009-01-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062912-003VANCOMYCIN HYDROCHLORIDEEQ 1.5GM BASE/VIALINJECTABLE / INJECTIONRS2020-07-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062912-001VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS1988-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062912-002VANCOMYCIN HYDROCHLORIDEEQ 750MG BASE/VIALINJECTABLE / INJECTIONAP2009-01-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062912-003VANCOMYCIN HYDROCHLORIDEEQ 1.5GM BASE/VIALINJECTABLE / INJECTIONRS2020-07-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062912-001VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS1988-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062912-002VANCOMYCIN HYDROCHLORIDEEQ 750MG BASE/VIALINJECTABLE / INJECTIONAP2009-01-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062912-003VANCOMYCIN HYDROCHLORIDEEQ 1.5GM BASE/VIALINJECTABLE / INJECTIONRS2020-07-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062912-001VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS1988-08-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062912-002VANCOMYCIN HYDROCHLORIDEEQ 750MG BASE/VIALINJECTABLE / INJECTIONAP2009-01-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062912-003VANCOMYCIN HYDROCHLORIDEEQ 1.5GM BASE/VIALINJECTABLE / INJECTIONRS2020-07-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062912-001VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS1988-08-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A062912-002VANCOMYCIN HYDROCHLORIDEEQ 750MG BASE/VIALINJECTABLE / INJECTIONAP2009-01-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A062912-003VANCOMYCIN HYDROCHLORIDEEQ 1.5GM BASE/VIALINJECTABLE / INJECTIONRS2020-07-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062912-001VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS1988-08-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062912-002VANCOMYCIN HYDROCHLORIDEEQ 750MG BASE/VIALINJECTABLE / INJECTIONAP2009-01-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062912-003VANCOMYCIN HYDROCHLORIDEEQ 1.5GM BASE/VIALINJECTABLE / INJECTIONRS2020-07-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062912-001VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS1988-08-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062912-002VANCOMYCIN HYDROCHLORIDEEQ 750MG BASE/VIALINJECTABLE / INJECTIONAP2009-01-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062912-003VANCOMYCIN HYDROCHLORIDEEQ 1.5GM BASE/VIALINJECTABLE / INJECTIONRS2020-07-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062912-001VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS1988-08-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062912-002VANCOMYCIN HYDROCHLORIDEEQ 750MG BASE/VIALINJECTABLE / INJECTIONAP2009-01-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062912-003VANCOMYCIN HYDROCHLORIDEEQ 1.5GM BASE/VIALINJECTABLE / INJECTIONRS2020-07-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062912-001VANCOMYCIN HYDROCHLORIDEEQ 1GM BASE/VIALINJECTABLE / INJECTIONAPRS1988-08-048072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A062912-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062912-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062912-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062912-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062912-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062912-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062912-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062912-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062912-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062912-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062912-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062912-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062912-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062912-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062912-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062912-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062912-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062912-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062912-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062912-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062912-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062912-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062912-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062912-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062912-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062912-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062912-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062912-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062912-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062912-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062912-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062912-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062912-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062912-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062912-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062912-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062912-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062912-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062912-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A062912-002AP1782e0a99824c…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDECivica, Inc3e041ec6-811b-4f26-9303-959cb09d5f572026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062912
application number: ANDA062912
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.f2901045-904f-47bd-74a1-c561facd7f252026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062912
application number: ANDA062912
ndc (product): 0409-6533
ndc (product): 0409-3515
ndc (product): 0409-6531
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.c9ea31ec-4c26-452f-b07b-c5f894212cd52026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062912
application number: ANDA062912
ndc (product): 0409-6533

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-3515Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-3515Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-3515Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-3515Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6531Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6531Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6531Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6531Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6531Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6531Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6531Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6531Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6531Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6531Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6531Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6531Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6531Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6531Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent
0409-6533Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39400SUPPL2014-02-03
18312SUPPL2012-07-30
30616SUPPL2009-01-09
8346SUPPL2009-01-09