FDA.reportPublic FDA data

Sodium Chloride

Product NDC
76297-001
11-digit product format
762970001
Labeler code
76297
Product ID
76297-001_ff5ef1ef-2a0d-476d-8483-ffd7cd47c635
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Chloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
LABORATORIOS GRIFOLS SA
Application
ANDA207956
Marketing category
ANDA
Marketing start
2017-05-25
Substance
SODIUM CHLORIDE
Active strength
9 g/1000mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM CHLORIDE9 g/1000mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii451W47IQ8X
Rxcui1807631, 1807632, 1807633, 1807634, 1807639

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
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
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
76297-001-01Sodium Chloride20 in 1 CARTONINJECTION, SOLUTION2018
76297-001-02Sodium Chloride500 mL in 1 BAGINJECTION, SOLUTION50018
76297-001-11Sodium Chloride115 in 1 CARTONINJECTION, SOLUTION11518
76297-001-12Sodium Chloride50 mL in 1 BAGINJECTION, SOLUTION5018
76297-001-21Sodium Chloride70 in 1 CARTONINJECTION, SOLUTION7018
76297-001-22Sodium Chloride100 mL in 1 BAGINJECTION, SOLUTION10018
76297-001-31Sodium Chloride28 in 1 CARTONINJECTION, SOLUTION2818
76297-001-32Sodium Chloride250 mL in 1 BAGINJECTION, SOLUTION25018
76297-001-41Sodium Chloride10 in 1 CARTONINJECTION, SOLUTION1018
76297-001-42Sodium Chloride1000 mL in 1 BAGINJECTION, SOLUTION100018
76297-001-51Sodium Chloride90 in 1 CARTONINJECTION, SOLUTION9018
76297-001-52Sodium Chloride50 mL in 1 BAGINJECTION, SOLUTION5018
76297-001-61Sodium Chloride50 in 1 CARTONINJECTION, SOLUTION5018
76297-001-62Sodium Chloride100 mL in 1 BAGINJECTION, SOLUTION10018
76297-001-71Sodium Chloride32 in 1 CARTONINJECTION, SOLUTION3218
76297-001-72Sodium Chloride250 mL in 1 BAGINJECTION, SOLUTION25018
76297-001-81Sodium Chloride24 in 1 CARTONINJECTION, SOLUTION2418
76297-001-82Sodium Chloride500 mL in 1 BAGINJECTION, SOLUTION50018
76297-001-91Sodium Chloride10 in 1 CARTONINJECTION, SOLUTION1018
76297-001-92Sodium Chloride1000 mL in 1 BAGINJECTION, SOLUTION100018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76297-001-01ML - Milliliter76297-001f5bb460d-deb8-482a-a2b9-233973381cd112018-03-08
76297-001-02ML - Milliliter76297-0011f740c02-4390-4ffb-a3c9-068563faaad912018-03-08
76297-001-11ML - Milliliter76297-001be4b70cb-8f1b-4f89-bfe8-ea4026d21f0612019-05-02
76297-001-12ML - Milliliter76297-0010d52bad0-eb30-4abd-9021-ab2c1546692712019-05-02
76297-001-21ML - Milliliter76297-001acf901fe-1dc7-4ba5-8577-cedb1d414f1812019-05-02
76297-001-22ML - Milliliter76297-001f8f58fd0-51aa-456e-ae70-ff2a8bf8743312019-05-02
76297-001-31ML - Milliliter76297-00176e25520-2b1a-498d-a1b5-45f68dd054aa12019-05-02
76297-001-32ML - Milliliter76297-0013fa192fe-00bd-4f8e-b877-ba6ea69eafb612019-05-02
76297-001-41ML - Milliliter76297-0014ad88a1d-afe1-4fc8-aa98-802472d8648b12019-05-02
76297-001-42ML - Milliliter76297-0011211f51a-47d9-4c53-bd58-810d3557823412019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76297-001SODIUM CHLORIDE INJECTION, SOLUTION [LABORATORIOS GRIFOLS SA]17Current NDC, Legacy NDC, 20 package rows20240702_eb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807632sodium chloride 0.9 % in 100 ML InjectionPSNeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf18
1807639sodium chloride 0.9 % in 1000 ML InjectionPSNeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf18
1807633sodium chloride 0.9 % in 250 ML InjectionPSNeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf18
1807631sodium chloride 0.9 % in 50 ML InjectionPSNeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf18
1807634sodium chloride 0.9 % in 500 ML InjectionPSNeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf18
1807632100 ML sodium chloride 9 MG/ML InjectionSCDeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf18
18076391000 ML sodium chloride 9 MG/ML InjectionSCDeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf18
1807633250 ML sodium chloride 9 MG/ML InjectionSCDeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf18
180763150 ML sodium chloride 9 MG/ML InjectionSCDeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf18
1807634500 ML sodium chloride 9 MG/ML InjectionSCDeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf18
1807632100 ML NaCl 9 MG/ML InjectionSYeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf18
18076391000 ML NaCl 9 MG/ML InjectionSYeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf18
1807633250 ML NaCl 9 MG/ML InjectionSYeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf18
180763150 ML NaCl 9 MG/ML InjectionSYeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf18
1807634500 ML NaCl 9 MG/ML InjectionSYeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf18
1807632sodium chloride 0.9 % per 100 ML InjectionSYeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf18
1807639sodium chloride 0.9 % per 1000 ML InjectionSYeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf18
1807633sodium chloride 0.9 % per 250 ML InjectionSYeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf18
1807631sodium chloride 0.9 % per 50 ML InjectionSYeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf18
1807634sodium chloride 0.9 % per 500 ML InjectionSYeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf18
1807634sodium chloride 0.9 % in 500 ML InjectionPSNe5247ed5-6170-c13f-e053-2a95a90a41012
1807634500 ML sodium chloride 9 MG/ML InjectionSCDe5247ed5-6170-c13f-e053-2a95a90a41012
1807634500 ML NaCl 9 MG/ML InjectionSYe5247ed5-6170-c13f-e053-2a95a90a41012
1807634sodium chloride 0.9 % per 500 ML InjectionSYe5247ed5-6170-c13f-e053-2a95a90a41012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76297-001-017629700010120 BAG in 1 CARTON (76297-001-01) / 500 mL in 1 BAG (76297-001-02) 20 bag2017-05-250000-00-00NoNoCurrent
76297-001-0276297000102500 mL in 1 BAG500 mlHistorical
76297-001-1176297000111115 BAG in 1 CARTON (76297-001-11) / 50 mL in 1 BAG (76297-001-12) 115 bag2018-12-010000-00-00NoNoCurrent
76297-001-127629700011250 mL in 1 BAG50 mlHistorical
76297-001-217629700012170 BAG in 1 CARTON (76297-001-21) / 100 mL in 1 BAG (76297-001-22) 70 bag2018-12-010000-00-00NoNoCurrent
76297-001-2276297000122100 mL in 1 BAG100 mlHistorical
76297-001-317629700013128 BAG in 1 CARTON (76297-001-31) / 250 mL in 1 BAG (76297-001-32) 28 bag2018-12-010000-00-00NoNoCurrent
76297-001-3276297000132250 mL in 1 BAG250 mlHistorical
76297-001-417629700014110 BAG in 1 CARTON (76297-001-41) / 1000 mL in 1 BAG (76297-001-42) 10 bag2019-03-010000-00-00NoNoCurrent
76297-001-42762970001421000 mL in 1 BAG1000 mlHistorical
76297-001-517629700015190 BAG in 1 CARTON (76297-001-51) / 50 mL in 1 BAG (76297-001-52) 90 bag2022-08-060000-00-00NoNoCurrent
76297-001-527629700015250 mL in 1 BAG50 mlHistorical
76297-001-617629700016150 BAG in 1 CARTON (76297-001-61) / 100 mL in 1 BAG (76297-001-62) 50 bag2022-08-060000-00-00NoNoCurrent
76297-001-6276297000162100 mL in 1 BAG100 mlHistorical
76297-001-717629700017132 BAG in 1 CARTON (76297-001-71) / 250 mL in 1 BAG (76297-001-72) 32 bag2022-08-060000-00-00NoNoCurrent
76297-001-7276297000172250 mL in 1 BAG250 mlHistorical
76297-001-817629700018124 BAG in 1 CARTON (76297-001-81) / 500 mL in 1 BAG (76297-001-82) 24 bag2022-08-060000-00-00NoNoCurrent
76297-001-8276297000182500 mL in 1 BAG500 mlHistorical
76297-001-917629700019110 BAG in 1 CARTON (76297-001-91) / 1000 mL in 1 BAG (76297-001-92)10 bag2026-05-310Current
76297-001-92762970001921000 mL in 1 BAG1000 mlHistorical