Sterile Water

Product NDC
55154-0127
11-digit product format
551540127
Labeler code
55154
Product ID
55154-0127_ae46b624-76f6-4866-8e6f-a0f2cfd63c61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
WATER
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Cardinal Health 107, LLC
Application
NDA018801
Marketing category
NDA
Marketing start
2011-09-15
Substance
WATER
Active strength
1 mL/mL
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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018801-001STERILE WATER FOR INJECTIONSTERILE WATER FOR INJECTION100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LIQUID / N/ARLD1982-10-27
N018801-002STERILE WATER FOR INJECTIONSTERILE WATER FOR INJECTION100% (10ML)LIQUID / N/AAPRLD, RS1982-10-27
N018801-003STERILE WATER FOR INJECTIONSTERILE WATER FOR INJECTION100% (20ML)LIQUID / N/AAPRLD, RS1982-10-27
N018801-004STERILE WATER FOR INJECTIONSTERILE WATER FOR INJECTION100% (50ML)LIQUID / N/ARLD, RS1982-10-27
N018801-005STERILE WATER FOR INJECTIONSTERILE WATER FOR INJECTION100% (100ML)LIQUID / N/ARLD, RS1982-10-27
N018801-006STERILE WATER FOR INJECTIONSTERILE WATER FOR INJECTION100% (5.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LIQUID / N/ARLD, RS2023-05-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N018801-002AP
N018801-003AP

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 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N018801-001STERILE WATER FOR INJECTION100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LIQUID / N/ARLD1982-10-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018801-002STERILE WATER FOR INJECTION100% (10ML)LIQUID / N/AAPRLD, RS1982-10-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018801-003STERILE WATER FOR INJECTION100% (20ML)LIQUID / N/AAPRLD, RS1982-10-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018801-004STERILE WATER FOR INJECTION100% (50ML)LIQUID / N/ARLD, RS1982-10-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018801-005STERILE WATER FOR INJECTION100% (100ML)LIQUID / N/ARLD, RS1982-10-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018801-006STERILE WATER FOR INJECTION100% (5.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LIQUID / N/ARLD, RS2023-05-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018801-001STERILE WATER FOR INJECTION100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LIQUID / N/ARLD1982-10-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018801-002STERILE WATER FOR INJECTION100% (10ML)LIQUID / N/AAPRLD, RS1982-10-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018801-003STERILE WATER FOR INJECTION100% (20ML)LIQUID / N/AAPRLD, RS1982-10-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018801-004STERILE WATER FOR INJECTION100% (50ML)LIQUID / N/ARLD, RS1982-10-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018801-005STERILE WATER FOR INJECTION100% (100ML)LIQUID / N/ARLD, RS1982-10-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018801-006STERILE WATER FOR INJECTION100% (5.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LIQUID / N/ARLD, RS2023-05-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N018801-001STERILE WATER FOR INJECTION100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LIQUID / N/ARLD1982-10-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018801-002STERILE WATER FOR INJECTION100% (10ML)LIQUID / N/AAPRLD, RS1982-10-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018801-003STERILE WATER FOR INJECTION100% (20ML)LIQUID / N/AAPRLD, RS1982-10-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018801-004STERILE WATER FOR INJECTION100% (50ML)LIQUID / N/ARLD, RS1982-10-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018801-005STERILE WATER FOR INJECTION100% (100ML)LIQUID / N/ARLD, RS1982-10-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018801-006STERILE WATER FOR INJECTION100% (5.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LIQUID / N/ARLD2023-05-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018801-001STERILE WATER FOR INJECTION100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LIQUID / N/ARLD1982-10-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018801-002STERILE WATER FOR INJECTION100% (10ML)LIQUID / N/AAPRLD, RS1982-10-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018801-003STERILE WATER FOR INJECTION100% (20ML)LIQUID / N/AAPRLD, RS1982-10-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018801-004STERILE WATER FOR INJECTION100% (50ML)LIQUID / N/ARLD, RS1982-10-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018801-005STERILE WATER FOR INJECTION100% (100ML)LIQUID / N/ARLD, RS1982-10-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018801-006STERILE WATER FOR INJECTION100% (5.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LIQUID / N/ARLD2023-05-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018801-001STERILE WATER FOR INJECTION100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LIQUID / N/ARLD1982-10-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018801-002STERILE WATER FOR INJECTION100% (10ML)LIQUID / N/AAPRLD, RS1982-10-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018801-003STERILE WATER FOR INJECTION100% (20ML)LIQUID / N/AAPRLD, RS1982-10-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018801-004STERILE WATER FOR INJECTION100% (50ML)LIQUID / N/ARLD, RS1982-10-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018801-005STERILE WATER FOR INJECTION100% (100ML)LIQUID / N/ARLD, RS1982-10-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018801-006STERILE WATER FOR INJECTION100% (5.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LIQUID / N/ARLD2023-05-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018801-001STERILE WATER FOR INJECTION100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LIQUID / N/ARLD1982-10-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018801-002STERILE WATER FOR INJECTION100% (10ML)LIQUID / N/AAPRLD, RS1982-10-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018801-003STERILE WATER FOR INJECTION100% (20ML)LIQUID / N/AAPRLD, RS1982-10-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018801-004STERILE WATER FOR INJECTION100% (50ML)LIQUID / N/ARLD, RS1982-10-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018801-005STERILE WATER FOR INJECTION100% (100ML)LIQUID / N/ARLD, RS1982-10-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018801-006STERILE WATER FOR INJECTION100% (5.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LIQUID / N/ARLD2023-05-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018801-001STERILE WATER FOR INJECTION100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LIQUID / N/ARLD1982-10-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018801-002STERILE WATER FOR INJECTION100% (10ML)LIQUID / N/AAPRLD, RS1982-10-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018801-003STERILE WATER FOR INJECTION100% (20ML)LIQUID / N/AAPRLD, RS1982-10-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018801-004STERILE WATER FOR INJECTION100% (50ML)LIQUID / N/ARLD, RS1982-10-272680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N018801-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N018801-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018801-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018801-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018801-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N018801-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018801-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018801-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018801-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018801-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018801-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018801-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018801-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018801-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018801-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018801-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018801-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018801-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018801-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N018801-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018801-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018801-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018801-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018801-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018801-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018801-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018801-002AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N018801-003AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018801-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018801-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018801-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018801-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018801-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018801-002AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018801-002AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N018801-002AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018801-002AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018801-002AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018801-002AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N018801-001AP1b00525d2431f…

Additional Listing Data#

Finished product
Yes
Brand name base
Sterile Water
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WATER1 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
059QF0KO0RInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9655cd02-82b5-4a75-813b-854b19551481Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-0127-5Sterile Water5 in 1 BAGINJECTION513
55154-0127-5Sterile Water10 mL in 1 VIAL, PLASTICINJECTION1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-0127-5ML - Milliliter55154-01270ecf64dd-67fc-479e-a418-e30cade67a9b12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-0127STERILE WATER (WATER) INJECTION [CARDINAL HEALTH 107, LLC]13Current NDC, Legacy NDC, 2 package rows20250410_9655cd02-82b5-4a75-813b-854b19551481.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 018801
application number: NDA018801
ndc (product): 55154-0127
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 018801
application number: NDA018801
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 018801
application number: NDA018801
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 018801
application number: NDA018801
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 018801
application number: NDA018801
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 018801
application number: NDA018801
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 018801
application number: NDA018801
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 018801
application number: NDA018801
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 018801
application number: NDA018801
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 018801
application number: NDA018801
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 018801
application number: NDA018801
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 018801
application number: NDA018801
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 018801
application number: NDA018801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-0127-5551540127055 VIAL, PLASTIC in 1 BAG (55154-0127-5) / 10 mL in 1 VIAL, PLASTIC2011-09-150000-00-00NoNoCurrent