Home Applications 062931 Application 062931
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 43 .
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 A062931-001 VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062931-001 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 · 43 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 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A062931-001 VANCOMYCIN HYDROCHLORIDE EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RS 1992-10-29 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 4 · 78 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Cameron Pharmaceuticals bc737938-ae36-460b-a2a8-609f3fe59156 2026-08-17 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride VANCOMYCIN HYDROCHLORIDE Aurobindo Pharma Limited e1008de0-8530-4998-8f8e-7d302e437e4f 2026-08-17 Warnings, Adverse reactions Name fallback brand name: vancomycin hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride VANCOMYCIN HYDROCHLORIDE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 127d95d1-8070-41ac-8343-3168b0cf1312 2026-08-05 Warnings, Adverse reactions Name fallback brand name: vancomycin hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Avenacy, LLC c757e65b-ca6f-4c00-afe2-025962b43d31 2026-07-31 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride VANCOMYCIN HYDROCHLORIDE Redpharm Drug 57d23aed-a3f7-f92e-e063-6394a90add7d 2026-07-30 Warnings, Adverse reactions Name fallback brand name: vancomycin hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Hospira, Inc. b01aaa02-8f1d-4b57-96a5-337503428af1 2026-07-20 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE FIRVANQ VANCOMYCIN HYDROCHLORIDE Azurity Pharmaceuticals, Inc 5aca5508-b577-446c-9980-ab4c7582b4b9 2026-07-14 Warnings, Adverse reactions Name fallback generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride for Oral Solution VANCOMYCIN HYDROCHLORIDE Wilshire Pharmaceuticals, Inc. 4c3d2e99-5351-4442-916a-d2001b0a5f5a 2026-07-14 Warnings, Adverse reactions Name fallback generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Meitheal Pharmaceuticals Inc. 033efc76-11d5-4a93-91de-56ed41bab9c3 2026-07-08 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Bryant Ranch Prepack 7bbd2c81-33d9-4397-8795-8b9fa28cb5cf 2026-06-26 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Bryant Ranch Prepack d6b8147b-5f93-49ee-8b27-78fe58987c90 2026-06-26 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Bryant Ranch Prepack 28fe3c01-cf87-41c0-87fd-f93a40524335 2026-06-16 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Eurofarma, Inc. 826510bd-b611-42d9-a574-ec7ee4151ef5 2026-06-12 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Bryant Ranch Prepack 6c74b360-022a-4c4d-9e4b-0988219a78fb 2026-06-12 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Bryant Ranch Prepack 8193f588-a032-451e-a0a1-819a5ea834c8 2026-06-12 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE Baxter Healthcare Corporation 99e523d8-9bde-43cb-8434-497015e5dcbd 2026-06-09 Warnings, Adverse reactions Name fallback brand name: VANCOMYCIN HYDROCHLORIDE generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Bryant Ranch Prepack a09c589b-e7f4-457c-827f-e1bfa1b26700 2026-05-26 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Bryant Ranch Prepack 786bde33-9aec-4b4d-ba46-90bfd61956d0 2026-05-26 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Bryant Ranch Prepack 9b6a7a21-4fde-40c6-a420-a8546a4dc701 2026-05-26 Warnings, Adverse reactions Name fallback brand name: Vancomycin Hydrochloride generic name: VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE VANCOMYCIN HYDROCHLORIDE Slate Run Pharmaceuticals, LLC 6ea38b4d-a6d2-4826-8110-ae42c9f7a42a 2026-05-15 Warnings, Adverse reactions Name fallback brand name: VANCOMYCIN HYDROCHLORIDE generic name: VANCOMYCIN HYDROCHLORIDE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0409-6534 Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Hospira, Inc. ANDA Current 0409-6534 Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Hospira, Inc. ANDA Current 0409-6534 Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Hospira, Inc. ANDA Current 0409-6534 Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Hospira, Inc. ANDA Current 0409-6534 Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Hospira, Inc. ANDA Current 0409-6534 Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Hospira, Inc. ANDA Current 0409-6534 Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Hospira, Inc. ANDA Current 0409-6534 Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Hospira, Inc. ANDA Current 0409-6534 Vancomycin Hydrochloride VANCOMYCIN HYDROCHLORIDE Hospira, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 39401 SUPPL 2012-07-30