Home NDC 63323-824 Dextrose
Product NDC 63323-824
11-digit product format 633230824
Labeler code 63323
Product ID 63323-824_0591ab74-99a6-40ee-af96-80bc2ef423dc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextrose Monohydrate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA209448
Marketing category ANDA
Marketing start 2019-03-29
Substance DEXTROSE MONOHYDRATE
Active strength 100 mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER DEXTROSE 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209448-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209448-001 DEXTROSE 10% IN PLASTIC CONTAINER 10GM/100ML INJECTABLE / INJECTION AP 2018-07-16 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Dextrose
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROSE MONOHYDRATE 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination LX22YL083G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1795477 Internal RxNorm lookup 1795480 Internal RxNorm lookup 1795481 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-824-24 Dextrose 250 mL in 1 BAG INJECTION, SOLUTION 250 5 63323-824-25 Dextrose 500 mL in 1 BAG INJECTION, SOLUTION 500 5 63323-824-26 Dextrose 1000 mL in 1 BAG INJECTION, SOLUTION 1000 5 63323-824-74 Dextrose 30 in 1 CASE INJECTION, SOLUTION 30 5 63323-824-75 Dextrose 20 in 1 CASE INJECTION, SOLUTION 20 5 63323-824-76 Dextrose 10 in 1 CASE INJECTION, SOLUTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-824 DEXTROSE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] 4 Current NDC, Legacy NDC, 6 package rows 20220224_3b8f2692-4371-4f1a-95af-b41842131fdd.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 · 3 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 63323-824-24 63323082424 250 mL in 1 BAG 250 ml Historical 63323-824-25 63323082425 500 mL in 1 BAG 500 ml Historical 63323-824-26 63323082426 1000 mL in 1 BAG 1000 ml Historical 63323-824-74 63323082474 30 BAG in 1 CASE (63323-824-74) / 250 mL in 1 BAG (63323-824-24) 30 bag 2019-03-29 0000-00-00 No No Current 63323-824-75 63323082475 20 BAG in 1 CASE (63323-824-75) / 500 mL in 1 BAG (63323-824-25) 20 bag 2019-03-29 0000-00-00 No No Current 63323-824-76 63323082476 10 BAG in 1 CASE (63323-824-76) / 1000 mL in 1 BAG (63323-824-26) 10 bag 2019-03-29 0000-00-00 No No Current