FDA.reportPublic FDA data

Dextrose and Sodium Chloride

Product NDC
17271-734
Requested package NDC
17271-734-06
11-digit product format
172710734
Labeler code
17271
Product ID
17271-734_cfe5e2b2-fe4e-4fa2-9dee-3197ac1de46d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXTROSE MONOHYDRATE and SODIUM CHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
BECTON DICKINSON AND COMPANY
Application
ANDA211276
Marketing category
ANDA
Marketing start
2020-10-26
Substance
DEXTROSE MONOHYDRATE; SODIUM CHLORIDE
Active strength
5; .45 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 1.

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
A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%DEXTROSE; SODIUM CHLORIDE5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211276-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-154b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTION2020-09-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-15c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-15cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211276-001DEXTROSE 5% AND SODIUM CHLORIDE 0.45%5GM/100ML;450MG/100MLINJECTABLE / INJECTIONAP2020-09-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211276-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211276-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211276-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211276-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211276-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211276-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211276-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211276-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211276-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211276-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211276-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211276-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211276-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211276-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211276-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211276-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211276-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211276-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211276-001AP1782e0a99824c…
2021-03-12 10:30 UTC2021-03A211276-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211276-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211276-001AP1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211276-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211276-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211276-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211276-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211276-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211276-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211276-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211276-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211276-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211276-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211276-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211276-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211276-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211276-001AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Dextrose and Sodium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROSE MONOHYDRATE5 g/100mL
SODIUM CHLORIDE.45 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1795250Internal RxNorm lookup
1795252Internal RxNorm lookup
1795254Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d3f90d2f-4536-4d32-800b-7a798f8a35dbAvailable 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
17271-734-05Dextrose and Sodium Chloride30 in 1 CASEINJECTION, SOLUTION304
17271-734-05Dextrose and Sodium Chloride250 mL in 1 BAGINJECTION, SOLUTION2504
17271-734-06Dextrose and Sodium Chloride500 mL in 1 BAGINJECTION, SOLUTION5004
17271-734-06Dextrose and Sodium Chloride20 in 1 CASEINJECTION, SOLUTION204
17271-734-07Dextrose and Sodium Chloride1000 mL in 1 BAGINJECTION, SOLUTION10004
17271-734-07Dextrose and Sodium Chloride10 in 1 CASEINJECTION, SOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17271-734DEXTROSE AND SODIUM CHLORIDE (DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE) INJECTION, SOLUTION [BECTON DICKINSON AND COMPANY]4Current NDC, 6 package rows20241120_d3f90d2f-4536-4d32-800b-7a798f8a35db.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBECTON DICKINSON AND COMPANYd3f90d2f-4536-4d32-800b-7a798f8a35db2024-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211276
application number: ANDA211276
ndc (package): 17271-734-06
ndc (product): 17271-734
ndc11 (package): 17271073406
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLC3c5f0f65-8a54-4a55-ad4e-0f0be97631d72024-09-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211276
application number: ANDA211276

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1795250dextrose 5 % / sodium chloride 0.45 % in 1000 ML InjectionPSNd3f90d2f-4536-4d32-800b-7a798f8a35db4
1795254dextrose 5 % / sodium chloride 0.45 % in 250 ML InjectionPSNd3f90d2f-4536-4d32-800b-7a798f8a35db4
1795252dextrose 5 % / sodium chloride 0.45 % in 500 ML InjectionPSNd3f90d2f-4536-4d32-800b-7a798f8a35db4
17952501000 ML glucose 50 MG/ML / sodium chloride 4.5 MG/ML InjectionSCDd3f90d2f-4536-4d32-800b-7a798f8a35db4
1795254250 ML glucose 50 MG/ML / sodium chloride 4.5 MG/ML InjectionSCDd3f90d2f-4536-4d32-800b-7a798f8a35db4
1795252500 ML glucose 50 MG/ML / sodium chloride 4.5 MG/ML InjectionSCDd3f90d2f-4536-4d32-800b-7a798f8a35db4
17952501000 ML Glucose 50 MG/ML / NaCl 4.5 MG/ML InjectionSYd3f90d2f-4536-4d32-800b-7a798f8a35db4
1795254250 ML Glucose 50 MG/ML / NaCl 4.5 MG/ML InjectionSYd3f90d2f-4536-4d32-800b-7a798f8a35db4
1795252500 ML Glucose 50 MG/ML / NaCl 4.5 MG/ML InjectionSYd3f90d2f-4536-4d32-800b-7a798f8a35db4
1795250dextrose 5 % / sodium chloride 0.45 % per 1000 ML InjectionSYd3f90d2f-4536-4d32-800b-7a798f8a35db4
1795254dextrose 5 % / sodium chloride 0.45 % per 250 ML InjectionSYd3f90d2f-4536-4d32-800b-7a798f8a35db4
1795252dextrose 5 % / sodium chloride 0.45 % per 500 ML InjectionSYd3f90d2f-4536-4d32-800b-7a798f8a35db4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17271-734-061727107340620 BAG in 1 CASE (17271-734-06) / 500 mL in 1 BAG20 bag2025-05-15NoNoCurrent