FDA.reportPublic FDA data

Dextrose and Sodium Chloride

Product NDC
0990-7941
11-digit product format
009907941
Labeler code
0990
Product ID
0990-7941_391a9854-64db-4da4-b8a5-a230001aa81c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXTROSE MONOHYDRATE and SODIUM CHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
ICU Medical Inc.
Application
NDA017585
Marketing category
NDA
Marketing start
2019-09-01
Substance
DEXTROSE MONOHYDRATE; SODIUM CHLORIDE
Active strength
5; .9 g/100mL; g/100mL
Pharmacologic classes
Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDE5GM/100ML;900MG/100MLINJECTABLE / 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
N017585-001AP

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 06:07:402026-07N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017585-001DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER5GM/100ML;900MG/100MLINJECTABLE / 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 06:07:402026-07N017585-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017585-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017585-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017585-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017585-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017585-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017585-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017585-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017585-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017585-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017585-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017585-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017585-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017585-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017585-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017585-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017585-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017585-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017585-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017585-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017585-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017585-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N017585-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017585-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017585-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017585-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N017585-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N017585-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017585-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017585-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017585-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017585-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017585-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017585-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017585-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N017585-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N017585-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017585-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017585-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017585-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Dextrose and Sodium Chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE5 g/100mL
SODIUM CHLORIDE.9 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LX22YL083GInternal UNII lookup
451W47IQ8XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1794902Internal RxNorm lookup
1794904Internal RxNorm lookup
1794905Internal RxNorm lookup
1795149Internal RxNorm lookup
1795150Internal RxNorm lookup
1795250Internal RxNorm lookup
1795252Internal RxNorm lookup
1795254Internal RxNorm lookup
1795344Internal RxNorm lookup
1795346Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4555b1bf-6d97-4798-a63d-6d34291c85ceAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0990-7941-03Dextrose and Sodium Chloride1 in 1 POUCHINJECTION, SOLUTION124
0990-7941-03Dextrose and Sodium Chloride24 in 1 CASEINJECTION, SOLUTION2424
0990-7941-09Dextrose and Sodium Chloride1 in 1 POUCHINJECTION, SOLUTION124
0990-7941-09Dextrose and Sodium Chloride12 in 1 CASEINJECTION, SOLUTION1224

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0990-7941-03ML - Milliliter0990-7941c5d0db73-491f-4e7e-bed2-7f4af1d2e5e612020-08-06
0990-7941-09ML - Milliliter0990-79416f8ea105-b0de-400c-9a52-f674bb70b25e12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0990-7941DEXTROSE AND SODIUM CHLORIDE (DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE) INJECTION, SOLUTION [ICU MEDICAL INC.]21Current NDC, Legacy NDC, 4 package rows20231202_4555b1bf-6d97-4798-a63d-6d34291c85ce.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEICU Medical Inc.4555b1bf-6d97-4798-a63d-6d34291c85ce2025-11-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 017585
application number: NDA017585
ndc (product): 0990-7941

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1794905dextrose 5 % / sodium chloride 0.225 % in 1000 ML InjectionPSN4555b1bf-6d97-4798-a63d-6d34291c85ce24
1794902dextrose 5 % / sodium chloride 0.225 % in 250 ML InjectionPSN4555b1bf-6d97-4798-a63d-6d34291c85ce24
1794904dextrose 5 % / sodium chloride 0.225 % in 500 ML InjectionPSN4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795150dextrose 5 % / sodium chloride 0.3 % in 1000 ML InjectionPSN4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795149dextrose 5 % / sodium chloride 0.3 % in 500 ML InjectionPSN4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795250dextrose 5 % / sodium chloride 0.45 % in 1000 ML InjectionPSN4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795254dextrose 5 % / sodium chloride 0.45 % in 250 ML InjectionPSN4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795252dextrose 5 % / sodium chloride 0.45 % in 500 ML InjectionPSN4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795346dextrose 5 % / sodium chloride 0.9 % in 1000 ML InjectionPSN4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795344dextrose 5 % / sodium chloride 0.9 % in 500 ML InjectionPSN4555b1bf-6d97-4798-a63d-6d34291c85ce24
17949051000 ML glucose 50 MG/ML / sodium chloride 2.25 MG/ML InjectionSCD4555b1bf-6d97-4798-a63d-6d34291c85ce24
17951501000 ML glucose 50 MG/ML / sodium chloride 3 MG/ML InjectionSCD4555b1bf-6d97-4798-a63d-6d34291c85ce24
17952501000 ML glucose 50 MG/ML / sodium chloride 4.5 MG/ML InjectionSCD4555b1bf-6d97-4798-a63d-6d34291c85ce24
17953461000 ML glucose 50 MG/ML / sodium chloride 9 MG/ML InjectionSCD4555b1bf-6d97-4798-a63d-6d34291c85ce24
1794902250 ML glucose 50 MG/ML / sodium chloride 2.25 MG/ML InjectionSCD4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795254250 ML glucose 50 MG/ML / sodium chloride 4.5 MG/ML InjectionSCD4555b1bf-6d97-4798-a63d-6d34291c85ce24
1794904500 ML glucose 50 MG/ML / sodium chloride 2.25 MG/ML InjectionSCD4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795149500 ML glucose 50 MG/ML / sodium chloride 3 MG/ML InjectionSCD4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795252500 ML glucose 50 MG/ML / sodium chloride 4.5 MG/ML InjectionSCD4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795344500 ML glucose 50 MG/ML / sodium chloride 9 MG/ML InjectionSCD4555b1bf-6d97-4798-a63d-6d34291c85ce24
17949051000 ML Glucose 50 MG/ML / NaCl 2.25 MG/ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
17951501000 ML Glucose 50 MG/ML / NaCl 3 MG/ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
17952501000 ML Glucose 50 MG/ML / NaCl 4.5 MG/ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
17953461000 ML Glucose 50 MG/ML / NaCl 9 MG/ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1794902250 ML Glucose 50 MG/ML / NaCl 2.25 MG/ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795254250 ML Glucose 50 MG/ML / NaCl 4.5 MG/ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1794904500 ML Glucose 50 MG/ML / NaCl 2.25 MG/ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795149500 ML Glucose 50 MG/ML / NaCl 3 MG/ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795252500 ML Glucose 50 MG/ML / NaCl 4.5 MG/ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795344500 ML Glucose 50 MG/ML / NaCl 9 MG/ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1794905dextrose 5 % / sodium chloride 0.225 % per 1000 ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1794902dextrose 5 % / sodium chloride 0.225 % per 250 ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1794904dextrose 5 % / sodium chloride 0.225 % per 500 ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795150dextrose 5 % / sodium chloride 0.3 % per 1000 ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795149dextrose 5 % / sodium chloride 0.3 % per 500 ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795250dextrose 5 % / sodium chloride 0.45 % per 1000 ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795254dextrose 5 % / sodium chloride 0.45 % per 250 ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795252dextrose 5 % / sodium chloride 0.45 % per 500 ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795346dextrose 5 % / sodium chloride 0.9 % per 1000 ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24
1795344dextrose 5 % / sodium chloride 0.9 % per 500 ML InjectionSY4555b1bf-6d97-4798-a63d-6d34291c85ce24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0990-7941-030099079410324 POUCH in 1 CASE (0990-7941-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG24 pouch2019-12-010000-00-00NoNoCurrent
0990-7941-090099079410912 POUCH in 1 CASE (0990-7941-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG12 pouch2019-11-150000-00-00NoNoCurrent