Home NDC 76329-3302 Dextrose Monohydrate
Product NDC 76329-3302
11-digit product format 763293302
Labeler code 76329
Product ID 76329-3302_45b366a9-6c0c-4643-9951-4ff880b29c83
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dextrose Monohydrate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler International Medication Systems, Limited
Application ANDA203451
Marketing category ANDA
Marketing start 2021-11-11
Substance DEXTROSE MONOHYDRATE
Active strength 25 g/50mL
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 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 A203451-001 DEXTROSE 50% DEXTROSE 500MG/ML INJECTABLE / INJECTION AP 2021-03-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203451-001 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.
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 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A203451-001 DEXTROSE 50% 500MG/ML INJECTABLE / INJECTION AP 2021-03-26 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Dextrose Monohydrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROSE MONOHYDRATE 25 g/50mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 727517 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 76329-3302-1 Dextrose Monohydrate 1 in 1 CARTON INJECTION, SOLUTION 1 5 76329-3302-1 Dextrose Monohydrate 50 mL in 1 SYRINGE INJECTION, SOLUTION 50 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76329-3302 DEXTROSE MONOHYDRATE (DEXTROSE MONOHYDRATE) INJECTION, SOLUTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ] 5 Current NDC, Legacy NDC, 2 package rows 20221221_fcc7ac79-cd70-4f03-a4de-f051f9ca1f7d.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 76329-3302-1 76329330201 1 SYRINGE in 1 CARTON (76329-3302-1) / 50 mL in 1 SYRINGE 1 syringe 2021-11-11 0000-00-00 No No Current