Application 016673

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSEINJECTABLE;INJECTION5GM/100MLYesYes
003DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSEINJECTABLE;INJECTION50MG/MLYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N016673-001DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016673-003DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N016673-001AP
N016673-003AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-30782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N016673-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016673-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016673-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016673-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N016673-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016673-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016673-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016673-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016673-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016673-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016673-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016673-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016673-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016673-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016673-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016673-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016673-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016673-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016673-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N016673-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016673-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016673-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016673-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016673-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016673-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016673-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016673-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N016673-003AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016673-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016673-003AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016673-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N016673-003AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016673-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N016673-003AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016673-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N016673-003AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N016673-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N016673-003AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N016673-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12N016673-003AP1782e0a99824c…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare Corporation3bb406a9-f5cb-403a-b1bb-5c4facbea3d52026-06-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 016673
application number: NDA016673
ndc (product): 0338-0017
DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare Corporation36e9478c-5df0-4b47-b97d-de3626d7cb292025-06-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 016673
application number: NDA016673
ndc (product): 0338-0074
ndc (product): 0338-0078
ndc (product): 0338-0070
ndc (product): 0338-0062
ndc (product): 0338-0066
ndc (product): 0338-0082

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 55 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0017DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare CorporationNDACurrent
0338-0017DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare CorporationNDACurrent
0338-0017DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare CorporationNDACurrent
0338-0017DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare CorporationNDACurrent
0338-0017DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare CorporationNDACurrent
0338-0017DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare CorporationNDACurrent
0338-0017DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare CorporationNDACurrent
0338-0062DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0062DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0062DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0062DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0062DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0062DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0062DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0066DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0066DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0066DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0066DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0066DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0066DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0066DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0070DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0070DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0070DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0070DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0070DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0070DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0070DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0074DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0074DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0074DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0074DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0074DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0074DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0074DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0078DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0078DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0078DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0078DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0078DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0078DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0078DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0082DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0082DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0082DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0082DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0082DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0082DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-0082DEXTROSEdextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-6346DextroseDextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-6346DextroseDextrose monohydrateBaxter Healthcare CorporationNDACurrent
0338-6346DextroseDextrose monohydrateBaxter Healthcare CorporationNDACurrent
55154-2885DEXTROSEDEXTROSE MONOHYDRATECardinal HealthNDACurrent
55154-2886DEXTROSEDEXTROSE MONOHYDRATECardinal HealthNDACurrent
55154-2887DEXTROSEDEXTROSE MONOHYDRATECardinal HealthNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81785SUPPL 2025-03-31
81783SUPPL 2025-03-31
59725SUPPL2019-08-15
59584SUPPL2019-08-06
10905SUPPL2015-01-09
472SUPPL2014-12-24