FDA.reportPublic FDA data

Sodium Chloride

Product NDC
63323-186
11-digit product format
633230186
Labeler code
63323
Product ID
63323-186_75c567e3-582b-4fff-9a72-f326f1d13c8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM CHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA088912
Marketing category
ANDA
Marketing start
2000-08-10
Substance
SODIUM CHLORIDE
Active strength
9 mg/mL
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM CHLORIDE9 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii451W47IQ8X
Rxcui1807636, 1807637, 1807638

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
95250459-30e4-45c1-b08a-993044f49109Product name220250805
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62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
a831e694-3663-4a83-82be-6c309429f750Product name220200608
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-186-01Sodium Chloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION109
63323-186-02Sodium Chloride25 in 1 TRAYINJECTION259
63323-186-03Sodium Chloride20 mL in 1 VIAL, SINGLE-DOSEINJECTION209
63323-186-04Sodium Chloride2 mL in 1 VIAL, SINGLE-DOSEINJECTION29
63323-186-10Sodium Chloride25 in 1 TRAYINJECTION259
63323-186-20Sodium Chloride25 in 1 TRAYINJECTION259

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-186-00ML - Milliliter63323-186631ef22b-45f3-4475-ac41-b8c42c80816612013-02-13
63323-186-01ML - Milliliter63323-186ad4d7cee-1556-46ad-804d-561c65beb25912019-11-12
63323-186-02ML - Milliliter63323-186a03cf0f1-7038-4766-bb04-a68590379e2c12013-02-13
63323-186-03ML - Milliliter63323-1862c9b6e64-5c28-473e-b4da-26594477ceaf12020-05-08
63323-186-10ML - Milliliter63323-186ef27364f-084d-489c-b30a-18d183641cd312016-04-04
63323-186-20ML - Milliliter63323-1864f06c3c9-0753-4b0e-8d0a-075b0d9169cd12016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XSODIUM CHLORIDE INJECTION [CARDINAL HEALTH]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XSODIUM CHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XSODIUM CHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698SODIUM CHLORIDE INJECTION [CARDINAL HEALTH]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698SODIUM CHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698SODIUM CHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBSODIUM CHLORIDE INJECTION [CARDINAL HEALTH]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBSODIUM CHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBSODIUM CHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISODIUM CHLORIDE INJECTION [CARDINAL HEALTH]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISODIUM CHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISODIUM CHLORIDE INJECTION [APP PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-186SODIUM CHLORIDE (SODIUM CHLORIDE) INJECTION [FRESENIUS KABI USA, LLC ]9Current NDC, Legacy NDC, 6 package rows20220215_f62481fd-fcdb-4be6-ac13-29c590e925c3.zip
63323-186SODIUM CHLORIDE INJECTION [FRESENIUS KABI USA, LLC]3Current NDC, Legacy NDC20241017_f2a98378-9678-4738-9670-fc7a215c0606.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807637sodium chloride 0.9 % in 10 ML InjectionPSN97007188-43fe-416c-a87b-6ccc4d9ae2ec10
180763710 ML sodium chloride 9 MG/ML InjectionSCD97007188-43fe-416c-a87b-6ccc4d9ae2ec10
180763710 ML NaCl 9 MG/ML InjectionSY97007188-43fe-416c-a87b-6ccc4d9ae2ec10
1807637normal saline 10 mL InjectionSY97007188-43fe-416c-a87b-6ccc4d9ae2ec10
1807637sodium chloride 0.9 % per 10 ML InjectionSY97007188-43fe-416c-a87b-6ccc4d9ae2ec10
1807637sodium chloride 0.9 % in 10 ML InjectionPSNf62481fd-fcdb-4be6-ac13-29c590e925c39
1807636sodium chloride 0.9 % in 2 ML InjectionPSNf62481fd-fcdb-4be6-ac13-29c590e925c39
1807638sodium chloride 0.9 % in 20 ML InjectionPSNf62481fd-fcdb-4be6-ac13-29c590e925c39
180763710 ML sodium chloride 9 MG/ML InjectionSCDf62481fd-fcdb-4be6-ac13-29c590e925c39
18076362 ML sodium chloride 9 MG/ML InjectionSCDf62481fd-fcdb-4be6-ac13-29c590e925c39
180763820 ML sodium chloride 9 MG/ML InjectionSCDf62481fd-fcdb-4be6-ac13-29c590e925c39
180763710 ML NaCl 9 MG/ML InjectionSYf62481fd-fcdb-4be6-ac13-29c590e925c39
18076362 ML NaCl 9 MG/ML InjectionSYf62481fd-fcdb-4be6-ac13-29c590e925c39
180763820 ML NaCl 9 MG/ML InjectionSYf62481fd-fcdb-4be6-ac13-29c590e925c39
1807637normal saline 10 mL InjectionSYf62481fd-fcdb-4be6-ac13-29c590e925c39
1807637sodium chloride 0.9 % per 10 ML InjectionSYf62481fd-fcdb-4be6-ac13-29c590e925c39
1807636sodium chloride 0.9 % per 2 ML InjectionSYf62481fd-fcdb-4be6-ac13-29c590e925c39
1807638sodium chloride 0.9 % per 20 ML InjectionSYf62481fd-fcdb-4be6-ac13-29c590e925c39
1807637sodium chloride 0.9 % in 10 ML InjectionPSNe0466bb3-6c26-4044-b051-69f48b67f6326
180763710 ML sodium chloride 9 MG/ML InjectionSCDe0466bb3-6c26-4044-b051-69f48b67f6326
180763710 ML NaCl 9 MG/ML InjectionSYe0466bb3-6c26-4044-b051-69f48b67f6326
1807637normal saline 10 mL InjectionSYe0466bb3-6c26-4044-b051-69f48b67f6326
1807637sodium chloride 0.9 % per 10 ML InjectionSYe0466bb3-6c26-4044-b051-69f48b67f6326
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSN56b90729-de15-4df9-9590-4da216fa9cd94
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSNa7bceca8-7dda-4fff-80de-01858b90c9284
797544isopropyl alcohol 70 % Medicated PadPSNa7bceca8-7dda-4fff-80de-01858b90c9284
797544isopropyl alcohol 70 % Medicated PadPSN56b90729-de15-4df9-9590-4da216fa9cd94
1085756Kenalog 40 MG/ML Injectable SuspensionPSN56b90729-de15-4df9-9590-4da216fa9cd94
1085756Kenalog 40 MG/ML Injectable SuspensionPSNa7bceca8-7dda-4fff-80de-01858b90c9284
1010033lidocaine HCl 1 % Injectable SolutionPSN56b90729-de15-4df9-9590-4da216fa9cd94
1010033lidocaine HCl 1 % Injectable SolutionPSNa7bceca8-7dda-4fff-80de-01858b90c9284
1012406Marcaine 0.5 % Injectable SolutionPSNa7bceca8-7dda-4fff-80de-01858b90c9284
1012406Marcaine 0.5 % Injectable SolutionPSN56b90729-de15-4df9-9590-4da216fa9cd94
312564povidone-iodine 10 % Topical SolutionPSN56b90729-de15-4df9-9590-4da216fa9cd94
312564povidone-iodine 10 % Topical SolutionPSNa7bceca8-7dda-4fff-80de-01858b90c9284
313002sodium chloride 0.9 % Injectable SolutionPSN56b90729-de15-4df9-9590-4da216fa9cd94
313002sodium chloride 0.9 % Injectable SolutionPSNa7bceca8-7dda-4fff-80de-01858b90c9284
1085754triamcinolone acetonide 40 MG/ML Injectable SuspensionPSN56b90729-de15-4df9-9590-4da216fa9cd94
1085754triamcinolone acetonide 40 MG/ML Injectable SuspensionPSNa7bceca8-7dda-4fff-80de-01858b90c9284
1010035Xylocaine 1 % Injectable SolutionPSNa7bceca8-7dda-4fff-80de-01858b90c9284
1010035Xylocaine 1 % Injectable SolutionPSN56b90729-de15-4df9-9590-4da216fa9cd94
1012406bupivacaine hydrochloride 5 MG/ML Injectable Solution [Marcaine]SBD56b90729-de15-4df9-9590-4da216fa9cd94
1012406bupivacaine hydrochloride 5 MG/ML Injectable Solution [Marcaine]SBDa7bceca8-7dda-4fff-80de-01858b90c9284
1010035lidocaine hydrochloride 10 MG/ML Injectable Solution [Xylocaine]SBDa7bceca8-7dda-4fff-80de-01858b90c9284
1010035lidocaine hydrochloride 10 MG/ML Injectable Solution [Xylocaine]SBD56b90729-de15-4df9-9590-4da216fa9cd94
1085756triamcinolone acetonide 40 MG/ML Injectable Suspension [Kenalog]SBD56b90729-de15-4df9-9590-4da216fa9cd94
1085756triamcinolone acetonide 40 MG/ML Injectable Suspension [Kenalog]SBDa7bceca8-7dda-4fff-80de-01858b90c9284
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCD56b90729-de15-4df9-9590-4da216fa9cd94
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCDa7bceca8-7dda-4fff-80de-01858b90c9284
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD56b90729-de15-4df9-9590-4da216fa9cd94
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCDa7bceca8-7dda-4fff-80de-01858b90c9284
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCDa7bceca8-7dda-4fff-80de-01858b90c9284
1010033lidocaine hydrochloride 10 MG/ML Injectable SolutionSCD56b90729-de15-4df9-9590-4da216fa9cd94
312564povidone-iodine 100 MG/ML Topical SolutionSCDa7bceca8-7dda-4fff-80de-01858b90c9284
312564povidone-iodine 100 MG/ML Topical SolutionSCD56b90729-de15-4df9-9590-4da216fa9cd94
313002sodium chloride 9 MG/ML Injectable SolutionSCD56b90729-de15-4df9-9590-4da216fa9cd94
313002sodium chloride 9 MG/ML Injectable SolutionSCDa7bceca8-7dda-4fff-80de-01858b90c9284
1085754triamcinolone acetonide 40 MG/ML Injectable SuspensionSCDa7bceca8-7dda-4fff-80de-01858b90c9284
1085754triamcinolone acetonide 40 MG/ML Injectable SuspensionSCD56b90729-de15-4df9-9590-4da216fa9cd94
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSY56b90729-de15-4df9-9590-4da216fa9cd94
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSYa7bceca8-7dda-4fff-80de-01858b90c9284
797544isopropyl alcohol 70 % Medicated PadSYa7bceca8-7dda-4fff-80de-01858b90c9284
797544isopropyl alcohol 70 % Medicated PadSY56b90729-de15-4df9-9590-4da216fa9cd94
797544isopropyl alcohol 70 % Topical ClothSYa7bceca8-7dda-4fff-80de-01858b90c9284
797544isopropyl alcohol 70 % Topical ClothSY56b90729-de15-4df9-9590-4da216fa9cd94
797544isopropyl alcohol 70 % Topical SwabSYa7bceca8-7dda-4fff-80de-01858b90c9284
797544isopropyl alcohol 70 % Topical SwabSY56b90729-de15-4df9-9590-4da216fa9cd94
1085756Kenalog 40 MG/ML Injectable SuspensionSYa7bceca8-7dda-4fff-80de-01858b90c9284
1085756Kenalog 40 MG/ML Injectable SuspensionSY56b90729-de15-4df9-9590-4da216fa9cd94
1085756Kenalog-40 40 MG/ML Injectable SuspensionSYa7bceca8-7dda-4fff-80de-01858b90c9284
1085756Kenalog-40 40 MG/ML Injectable SuspensionSY56b90729-de15-4df9-9590-4da216fa9cd94
1010033lidocaine hydrochloride 1 % Injectable SolutionSYa7bceca8-7dda-4fff-80de-01858b90c9284
1010033lidocaine hydrochloride 1 % Injectable SolutionSY56b90729-de15-4df9-9590-4da216fa9cd94
1012406Marcaine 0.5 % Injectable SolutionSYa7bceca8-7dda-4fff-80de-01858b90c9284
1012406Marcaine 0.5 % Injectable SolutionSY56b90729-de15-4df9-9590-4da216fa9cd94
1012406Marcaine 5 MG/ML Injectable SolutionSY56b90729-de15-4df9-9590-4da216fa9cd94
1012406Marcaine 5 MG/ML Injectable SolutionSYa7bceca8-7dda-4fff-80de-01858b90c9284
313002NaCl 9 MG/ML Injectable SolutionSYa7bceca8-7dda-4fff-80de-01858b90c9284
313002NaCl 9 MG/ML Injectable SolutionSY56b90729-de15-4df9-9590-4da216fa9cd94
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSYa7bceca8-7dda-4fff-80de-01858b90c9284

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-186-006332301860025 VIAL, SINGLE-DOSE in 1 TRAY (63323-186-00) > 100 mL in 1 VIAL, SINGLE-DOSE2000-08-100000-00-00NoNoCurrent
63323-186-016332301860110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
63323-186-026332301860225 VIAL, SINGLE-DOSE in 1 TRAY (63323-186-02) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-186-04) 2000-08-100000-00-00NoNoCurrent
63323-186-036332301860320 mL in 1 VIAL, SINGLE-DOSE20 mlHistorical
63323-186-04633230186042 mL in 1 VIAL, SINGLE-DOSE2 mlHistorical
63323-186-106332301861025 VIAL, SINGLE-DOSE in 1 TRAY (63323-186-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-186-01) 2000-08-100000-00-00NoNoCurrent
63323-186-206332301862025 VIAL, SINGLE-DOSE in 1 TRAY (63323-186-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-186-03) 2000-08-100000-00-00NoNoCurrent