Home NDC 63323-011 Chloramphenicol Sodium Succinate
Product NDC 63323-011
11-digit product format 633230011
Labeler code 63323
Product ID 63323-011_f0af962d-5024-47cf-b7a0-da9b5ff3c994
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CHLORAMPHENICOL SODIUM SUCCINATE
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA062365
Marketing category ANDA
Marketing start 2001-01-12
Substance CHLORAMPHENICOL SODIUM SUCCINATE
Active strength 1 g/10mL
Pharmacologic classes Amphenicol-class Antibacterial [EPC], Amphenicols [EXT]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing 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 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1982-08-25
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 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1982-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1982-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1982-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1982-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1982-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1982-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1982-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1982-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1982-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1982-08-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1982-08-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1982-08-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1982-08-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1982-08-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION 1982-08-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A062365-001 CHLORAMPHENICOL SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE / INJECTION RS 1982-08-25 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Chloramphenicol Sodium Succinate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORAMPHENICOL SODIUM SUCCINATE 1 g/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 872109HX6B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 239200 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-011-15 Chloramphenicol Sodium Succinate 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 6 63323-011-15 Chloramphenicol Sodium Succinate 10 in 1 TRAY INJECTION, POWDER, LYOPHILIZED, 10 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHLORAMPHENICOL SODIUM SUCCINATE ACTIVE INGREDIENT 872109HX6B CHLORAMPHENICOL SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2 CHLORAMPHENICOL ACTIVE MOIETY 66974FR9Q1 CHLORAMPHENICOL SODIUM SUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-011 CHLORAMPHENICOL SODIUM SUCCINATE (CHLORAMPHENICOL SODIUM SUCCINATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20241013_aed29594-211d-49ef-813f-131975a8d0e3.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 63323-011-15 63323001115 10 VIAL in 1 TRAY (63323-011-15) / 10 mL in 1 VIAL 10 vial 2001-01-12 0000-00-00 No No Current