Dextrose

Product NDC
0409-7922
Requested package NDC
0409-7922-09
11-digit product format
004097922
Labeler code
0409
Product ID
0409-7922_c1d63653-481f-425a-a260-77c6b502fb3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dextrose monohydrate
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA016367
Marketing category
NDA
Marketing start
2005-02-28
Marketing end
2021-08-01
Substance
DEXTROSE MONOHYDRATE
Active strength
5 g/100mL
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0409-79220409-7922-09DDiscontinued by firm2026-08-17

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N016367-002DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N016367-002AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N016367-002DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N016367-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016367-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016367-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N016367-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016367-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016367-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016367-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016367-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016367-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016367-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016367-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016367-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016367-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016367-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016367-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016367-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016367-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016367-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016367-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N016367-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N016367-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N016367-002AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N016367-002AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N016367-002AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N016367-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N016367-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N016367-002AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N016367-002AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N016367-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N016367-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N016367-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N016367-002AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N016367-002AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N016367-002AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N016367-002AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N016367-002AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N016367-002AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N016367-002AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N016367-002AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N016367-002AP1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-7922-02ML - Milliliter0409-7922fa6d08f3-f789-4f77-a67c-0825aef5bd9112012-07-24
0409-7922-03ML - Milliliter0409-79222dfae48b-26da-4298-a00e-10079512a49b12012-07-24
0409-7922-09ML - Milliliter0409-7922130b8e74-6e49-45c5-bb48-ab547f59c60a12012-07-24
0409-7922-25ML - Milliliter0409-7922b2761a76-9dda-46fd-a2c0-afc3c0b72b4e12012-07-24
0409-7922-30ML - Milliliter0409-79223c6beb92-1055-4611-8207-91bed4d67c3012012-07-24
0409-7922-48ML - Milliliter0409-79228bde8ea0-8adf-4242-94a9-b0cb2eb4cdcd12012-07-24
0409-7922-53ML - Milliliter0409-7922f153a7e3-45f9-4922-8f29-9c05f33324e112012-07-24
0409-7922-55ML - Milliliter0409-7922b2138e10-ef32-48fd-94b0-b9edcc601d5512012-07-24
0409-7922-61ML - Milliliter0409-7922cd7baacc-54ce-4d57-9ec3-a06ca64b9e5f12012-07-24

DailyMed Socrata Ingredients#

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DextroseDEXTROSE MONOHYDRATEICU Medical, Inc.8b25b7e0-703e-4b43-a4eb-52863511602d2025-11-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 016367
application number: NDA016367

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1795609dextrose 5 % in 100 ML InjectionPSN7790c2ce-2f46-7c4d-e053-2991aa0a7eda4
1795610dextrose 5 % in 250 ML InjectionPSN7790c2ce-2f46-7c4d-e053-2991aa0a7eda4
1795609100 ML glucose 50 MG/ML InjectionSCD7790c2ce-2f46-7c4d-e053-2991aa0a7eda4
1795610250 ML glucose 50 MG/ML InjectionSCD7790c2ce-2f46-7c4d-e053-2991aa0a7eda4
1795609dextrose 5 % per 100 ML InjectionSY7790c2ce-2f46-7c4d-e053-2991aa0a7eda4
1795610dextrose 5 % per 250 ML InjectionSY7790c2ce-2f46-7c4d-e053-2991aa0a7eda4
1795607dextrose 5 % in 500 ML InjectionPSN78817e19-875d-1008-e053-2991aa0ae4673
1795607500 ML glucose 50 MG/ML InjectionSCD78817e19-875d-1008-e053-2991aa0ae4673
1795607dextrose 5 % per 500 ML InjectionSY78817e19-875d-1008-e053-2991aa0ae4673

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-7922-090040979220912 POUCH in 1 CASE (0409-7922-09) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG12 pouch2005-02-282021-08-01NoNoCurrent