Home NDC 57970-100 DALVANCE
Product NDC 57970-100
11-digit product format 579700100
Labeler code 57970
Product ID 57970-100_c8fc5d09-57d1-4c85-aa4d-6bde6a25dcab
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dalbavancin
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Allergan, Inc.
Application NDA021883
Marketing category NDA
Marketing start 2014-05-23
Substance DALBAVANCIN HYDROCHLORIDE
Active strength 500 mg/25mL
Pharmacologic classes Lipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-08-27 00:01 UTC · source 2025-08-26 excluded product product 57970-100 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 57970-100 57970-100-01 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 N021883-001 DALVANCE DALBAVANCIN HYDROCHLORIDE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2014-05-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021883-001 AP
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021883-001 6900175 2028-05-23 U-3499 2014-06-13
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 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2014-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS AP RLD, RS 2014-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021883-001 DALVANCE EQ 500MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2014-05-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021883-001 AP 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021883-001 AP 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021883-001 AP 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 113 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021883-001 6900175 2028-05-23 U-3499 2014-06-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021883-001 7115564 2023-11-14 Drug product 2014-06-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021883-001 7119061 2023-11-14 Drug product 2014-06-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021883-001 8143212 2023-11-14 U-1517 2014-06-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021883-001 6900175 2023-12-25 U-1517 2014-06-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021883-001 7115564 2023-11-14 Drug product 2014-06-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021883-001 7119061 2023-11-14 Drug product 2014-06-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021883-001 8143212 2023-11-14 U-1517 2014-06-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021883-001 6900175 2023-12-25 U-1517 2014-06-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021883-001 7115564 2023-11-14 Drug product 2014-06-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021883-001 7119061 2023-11-14 Drug product 2014-06-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021883-001 8143212 2023-11-14 U-1517 2014-06-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021883-001 6900175 2023-12-25 U-1517 2014-06-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021883-001 7115564 2023-11-14 Drug product 2014-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021883-001 7119061 2023-11-14 Drug product 2014-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021883-001 8143212 2023-11-14 U-1517 2014-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021883-001 6900175 2023-12-25 U-1517 2014-06-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021883-001 7115564 2023-11-14 Drug product 2014-06-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021883-001 7119061 2023-11-14 Drug product 2014-06-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021883-001 8143212 2023-11-14 U-1517 2014-06-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021883-001 6900175 2023-12-25 U-1517 2014-06-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021883-001 7115564 2023-11-14 Drug product 2014-06-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021883-001 7119061 2023-11-14 Drug product 2014-06-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021883-001 8143212 2023-11-14 U-1517 2014-06-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021883-001 6900175 2023-12-25 U-1517 2014-06-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021883-001 7115564 2023-11-14 Drug product 2014-06-13 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021883-001 7119061 2023-11-14 Drug product 2014-06-13 87673890dc5c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 101 observed states.
Additional Listing Data#
Finished product Yes
Brand name base DALVANCE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DALBAVANCIN HYDROCHLORIDE 500 mg/25mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 33WDQ7T81E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1539243 Internal RxNorm lookup 1539248 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# Effective, Related label table Effective Related label 2025-11-07 These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014 2025-11-07 These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014 2025-07-29 These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014 2025-07-29 These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014 2024-01-30 These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014 2024-01-30 These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014 2020-07-30 These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014 2020-07-30 These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014 2020-07-22 These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014 2020-07-22 These highlights do not include all the information needed to use DALVANCE ® safely and effectively. See full prescribing information for DALVANCE . DALVANCE ( dalbavancin ) for injection , for intravenous use Initial U.S. Approval: 2014
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57970-100-01 DALVANCE 1 in 1 PACKAGE INJECTION, POWDER, FOR SOLUTION 1 29 57970-100-01 DALVANCE 25 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 25 29
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DALBAVANCIN HYDROCHLORIDE ACTIVE INGREDIENT 33WDQ7T81E DALVANCE (DALBAVANCIN) INJECTION, POWDER, FOR SOLUTION [DURATA THERAPEUTICS INC.] 12 DALBAVANCIN ACTIVE MOIETY 808UI9MS5K DALVANCE (DALBAVANCIN) INJECTION, POWDER, FOR SOLUTION [DURATA THERAPEUTICS INC.] 12 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DALVANCE (DALBAVANCIN) INJECTION, POWDER, FOR SOLUTION [DURATA THERAPEUTICS INC.] 12 MANNITOL INACTIVE INGREDIENT 3OWL53L36A DALVANCE (DALBAVANCIN) INJECTION, POWDER, FOR SOLUTION [DURATA THERAPEUTICS INC.] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57970-100 DALVANCE (DALBAVANCIN) INJECTION, POWDER, FOR SOLUTION [ALLERGAN, INC.] 28 Current NDC, Legacy NDC, 2 package rows 20250228_4b4674d8-4d1e-4728-8465-d42ada33fa5c.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57970-100-01 57970010001 1 VIAL in 1 PACKAGE (57970-100-01) / 25 mL in 1 VIAL 1 vial 2014-05-23 0000-00-00 No No Current