Home NDC 61570-260-10 Synercid
Product NDC 61570-260
Requested package NDC 61570-260-10
11-digit product format 615700260
Labeler code 61570
Product ID 61570-260_e4ced767-b3af-4a33-845d-687ea3198695
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name quinupristin and dalfopristin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA050748
Marketing category NDA
Marketing start 1999-09-21
Marketing end 0000-00-00
Substance DALFOPRISTIN; QUINUPRISTIN
Active strength 350 mg/5mL; mg/5mL
Pharmacologic classes Streptogramin Antibacterial [EPC], Streptogramin Antibacterial [EPC], Streptogramins [CS], Streptogramins [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050748-001 SYNERCID DALFOPRISTIN; QUINUPRISTIN 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD 1999-09-21 N050748-002 SYNERCID DALFOPRISTIN; QUINUPRISTIN 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24
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 · 82 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 N050748-001 SYNERCID 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD 1999-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050748-002 SYNERCID 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050748-001 SYNERCID 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD 1999-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050748-002 SYNERCID 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050748-001 SYNERCID 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD 1999-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050748-002 SYNERCID 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050748-001 SYNERCID 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD 1999-09-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050748-002 SYNERCID 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050748-001 SYNERCID 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD 1999-09-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050748-002 SYNERCID 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050748-001 SYNERCID 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD 1999-09-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050748-002 SYNERCID 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050748-001 SYNERCID 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD 1999-09-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050748-002 SYNERCID 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050748-001 SYNERCID 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 1999-09-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050748-002 SYNERCID 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050748-001 SYNERCID 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD 1999-09-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050748-002 SYNERCID 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050748-001 SYNERCID 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD 1999-09-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050748-002 SYNERCID 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050748-001 SYNERCID 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 1999-09-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050748-002 SYNERCID 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050748-001 SYNERCID 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 1999-09-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050748-002 SYNERCID 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050748-001 SYNERCID 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 1999-09-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050748-002 SYNERCID 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050748-001 SYNERCID 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 1999-09-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050748-002 SYNERCID 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050748-001 SYNERCID 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 1999-09-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050748-002 SYNERCID 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050748-001 SYNERCID 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 1999-09-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050748-002 SYNERCID 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050748-001 SYNERCID 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 1999-09-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050748-002 SYNERCID 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050748-001 SYNERCID 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 1999-09-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050748-002 SYNERCID 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050748-001 SYNERCID 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 1999-09-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N050748-002 SYNERCID 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050748-001 SYNERCID 350MG/VIAL;150MG/VIAL INJECTABLE / INTRAVENOUS RLD, RS 1999-09-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N050748-002 SYNERCID 420MG/VIAL;180MG/VIAL INJECTABLE / INTRAVENOUS 2000-08-24 782e0a99824c…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DALFOPRISTIN ACTIVE INGREDIENT R9M4FJE48E SYNERCID (QUINUPRISTIN AND DALFOPRISTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] 8 QUINUPRISTIN ACTIVE INGREDIENT 23OW28RS7P SYNERCID (QUINUPRISTIN AND DALFOPRISTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] 8 DALFOPRISTIN ACTIVE MOIETY R9M4FJE48E SYNERCID (QUINUPRISTIN AND DALFOPRISTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] 8 QUINUPRISTIN ACTIVE MOIETY 23OW28RS7P SYNERCID (QUINUPRISTIN AND DALFOPRISTIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] 8
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 61570-260-10 61570026010 10 VIAL, GLASS in 1 CARTON (61570-260-10) > 5 mL in 1 VIAL, GLASS (61570-260-01) 1999-09-21 0000-00-00 No No Current