Sterile Water

Product NDC
71872-7182
Requested package NDC
71872-7182-1
11-digit product format
718727182
Labeler code
71872
Product ID
71872-7182_9c98524b-1543-fe23-e053-2a95a90acc36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
WATER
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Medical Purchasing Solutions, LLC
Application
NDA018801
Marketing category
NDA
Marketing start
2005-06-16
Marketing end
0000-00-00
Substance
WATER
Active strength
1 mL/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71872-718271872-7182-1IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71872-7182-12025-01-30C16284748780-12cef2736-68b0-d83d-e063-dadaa90ab31fSterile Water Rx only for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71872-7182-1Sterile Water10 mL in 1 VIAL, PLASTICINJECTION101
71872-7182-1Sterile Water1 in 1 BAGINJECTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7182STERILE WATER (WATER) INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC]1Legacy NDC, 2 package rows20200121_9c9851b6-2702-e893-e053-2a95a90a729c.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
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
71872-7182-1718727182011 VIAL, PLASTIC in 1 BAG (71872-7182-1) > 10 mL in 1 VIAL, PLASTIC2020-11-120000-00-00NoNoCurrent