Sodium Chloride

Product NDC
84549-049
11-digit product format
845490049
Labeler code
84549
Product ID
84549-049_463e84b2-a9e7-fde6-e063-6294a90ab983
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Chloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
ProPharma Distribution
Application
NDA016677
Marketing category
NDA
Marketing start
1970-12-09
Substance
SODIUM CHLORIDE
Active strength
9 g/1000mL
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDE900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 1982
N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDE450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 1982
N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDE225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, 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
N016677-001AP
N016677-003AP

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 · 103 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016677-003SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER450MG/50ML (9MG/ML)SOLUTION / INJECTIONAPRLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016677-004SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER225MG/25ML (9MG/ML)SOLUTION / INJECTIONRLD, RS1985-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016677-001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER900MG/100MLSOLUTION / INJECTIONAPRLD, RS, Approved before 19828072bd15b7f6…

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 UTC2026-02N016677-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016677-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016677-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016677-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N016677-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016677-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016677-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016677-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016677-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016677-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016677-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016677-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016677-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016677-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016677-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016677-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016677-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016677-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016677-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N016677-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016677-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016677-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016677-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016677-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016677-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016677-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016677-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N016677-003AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016677-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016677-004AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016677-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N016677-004AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016677-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N016677-004AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016677-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N016677-004AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N016677-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N016677-004AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N016677-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12N016677-004AP1782e0a99824c…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1807632Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3f79fb8b-d0e8-db2a-e063-6394a90ac136Available 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
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
84549-049-48Sodium Chloride100 mL in 1 BAGINJECTION, SOLUTION1002

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDESportpharm LLCa2c111f6-74d5-4a5d-82ac-d0f237488cb82026-04-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 016677
application number: NDA016677
Sodium ChlorideSODIUM CHLORIDEProPharma Distribution3f79fb8b-d0e8-db2a-e063-6394a90ac1362025-12-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 016677
application number: NDA016677
ndc (product): 84549-049
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporation958d35f0-6834-43be-a700-fa58f38b4c192025-06-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 016677
application number: NDA016677
Sodium ChlorideSODIUM CHLORIDEBaxter Healthcare Corporationf55bd888-5e01-474d-871b-24654c0701782024-07-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 016677
application number: NDA016677

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807632sodium chloride 0.9 % in 100 ML InjectionPSN3f79fb8b-d0e8-db2a-e063-6394a90ac1362
1807632100 ML sodium chloride 9 MG/ML InjectionSCD3f79fb8b-d0e8-db2a-e063-6394a90ac1362
1807632100 ML NaCl 9 MG/ML InjectionSY3f79fb8b-d0e8-db2a-e063-6394a90ac1362
1807632sodium chloride 0.9 % per 100 ML InjectionSY3f79fb8b-d0e8-db2a-e063-6394a90ac1362

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84549-049-4884549004948100 mL in 1 BAG (84549-049-48) 100 ml2025-09-23NoNoCurrent