Sterile Water
- Product NDC
- 71872-7041
- Requested package NDC
- 71872-7041-1
- 11-digit product format
- 718727041
- Labeler code
- 71872
- Product ID
- 71872-7041_81a1a49e-fd8a-59d8-e053-2a91aa0ac3c3
- 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
- Substance
- WATER
- Active strength
- 1 mL/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 71872-7041 | 71872-7041-1 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018801-001 | STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LIQUID / N/A | RLD | 1982-10-27 | |
| N018801-002 | STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (10ML) | LIQUID / N/A | AP | RLD, RS | 1982-10-27 |
| N018801-003 | STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (20ML) | LIQUID / N/A | AP | RLD, RS | 1982-10-27 |
| N018801-004 | STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (50ML) | LIQUID / N/A | RLD, RS | 1982-10-27 | |
| N018801-005 | STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (100ML) | LIQUID / N/A | RLD, RS | 1982-10-27 | |
| N018801-006 | STERILE WATER FOR INJECTION | STERILE WATER FOR INJECTION | 100% (5.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LIQUID / N/A | RLD, RS | 2023-05-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N018801-002 | AP |
| N018801-003 | AP |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N018801-001 | STERILE WATER FOR INJECTION | 100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LIQUID / N/A | RLD | 1982-10-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018801-002 | STERILE WATER FOR INJECTION | 100% (10ML) | LIQUID / N/A | AP | RLD, RS | 1982-10-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018801-003 | STERILE WATER FOR INJECTION | 100% (20ML) | LIQUID / N/A | AP | RLD, RS | 1982-10-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018801-004 | STERILE WATER FOR INJECTION | 100% (50ML) | LIQUID / N/A | RLD, RS | 1982-10-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018801-005 | STERILE WATER FOR INJECTION | 100% (100ML) | LIQUID / N/A | RLD, RS | 1982-10-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018801-006 | STERILE WATER FOR INJECTION | 100% (5.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LIQUID / N/A | RLD, RS | 2023-05-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018801-001 | STERILE WATER FOR INJECTION | 100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LIQUID / N/A | RLD | 1982-10-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018801-002 | STERILE WATER FOR INJECTION | 100% (10ML) | LIQUID / N/A | AP | RLD, RS | 1982-10-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018801-003 | STERILE WATER FOR INJECTION | 100% (20ML) | LIQUID / N/A | AP | RLD, RS | 1982-10-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018801-004 | STERILE WATER FOR INJECTION | 100% (50ML) | LIQUID / N/A | RLD, RS | 1982-10-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018801-005 | STERILE WATER FOR INJECTION | 100% (100ML) | LIQUID / N/A | RLD, RS | 1982-10-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018801-006 | STERILE WATER FOR INJECTION | 100% (5.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LIQUID / N/A | RLD, RS | 2023-05-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018801-001 | STERILE WATER FOR INJECTION | 100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LIQUID / N/A | RLD | 1982-10-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018801-002 | STERILE WATER FOR INJECTION | 100% (10ML) | LIQUID / N/A | AP | RLD, RS | 1982-10-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018801-003 | STERILE WATER FOR INJECTION | 100% (20ML) | LIQUID / N/A | AP | RLD, RS | 1982-10-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018801-004 | STERILE WATER FOR INJECTION | 100% (50ML) | LIQUID / N/A | RLD, RS | 1982-10-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018801-005 | STERILE WATER FOR INJECTION | 100% (100ML) | LIQUID / N/A | RLD, RS | 1982-10-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018801-006 | STERILE WATER FOR INJECTION | 100% (5.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LIQUID / N/A | RLD | 2023-05-02 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018801-001 | STERILE WATER FOR INJECTION | 100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LIQUID / N/A | RLD | 1982-10-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018801-002 | STERILE WATER FOR INJECTION | 100% (10ML) | LIQUID / N/A | AP | RLD, RS | 1982-10-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018801-003 | STERILE WATER FOR INJECTION | 100% (20ML) | LIQUID / N/A | AP | RLD, RS | 1982-10-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018801-004 | STERILE WATER FOR INJECTION | 100% (50ML) | LIQUID / N/A | RLD, RS | 1982-10-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018801-005 | STERILE WATER FOR INJECTION | 100% (100ML) | LIQUID / N/A | RLD, RS | 1982-10-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018801-006 | STERILE WATER FOR INJECTION | 100% (5.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LIQUID / N/A | RLD | 2023-05-02 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018801-001 | STERILE WATER FOR INJECTION | 100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LIQUID / N/A | RLD | 1982-10-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018801-002 | STERILE WATER FOR INJECTION | 100% (10ML) | LIQUID / N/A | AP | RLD, RS | 1982-10-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018801-003 | STERILE WATER FOR INJECTION | 100% (20ML) | LIQUID / N/A | AP | RLD, RS | 1982-10-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018801-004 | STERILE WATER FOR INJECTION | 100% (50ML) | LIQUID / N/A | RLD, RS | 1982-10-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018801-005 | STERILE WATER FOR INJECTION | 100% (100ML) | LIQUID / N/A | RLD, RS | 1982-10-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018801-006 | STERILE WATER FOR INJECTION | 100% (5.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LIQUID / N/A | RLD | 2023-05-02 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018801-001 | STERILE WATER FOR INJECTION | 100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LIQUID / N/A | RLD | 1982-10-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018801-002 | STERILE WATER FOR INJECTION | 100% (10ML) | LIQUID / N/A | AP | RLD, RS | 1982-10-27 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018801-003 | STERILE WATER FOR INJECTION | 100% (20ML) | LIQUID / N/A | AP | RLD, RS | 1982-10-27 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018801-004 | STERILE WATER FOR INJECTION | 100% (50ML) | LIQUID / N/A | RLD, RS | 1982-10-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018801-005 | STERILE WATER FOR INJECTION | 100% (100ML) | LIQUID / N/A | RLD, RS | 1982-10-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018801-006 | STERILE WATER FOR INJECTION | 100% (5.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LIQUID / N/A | RLD | 2023-05-02 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018801-001 | STERILE WATER FOR INJECTION | 100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LIQUID / N/A | RLD | 1982-10-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018801-002 | STERILE WATER FOR INJECTION | 100% (10ML) | LIQUID / N/A | AP | RLD, RS | 1982-10-27 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018801-003 | STERILE WATER FOR INJECTION | 100% (20ML) | LIQUID / N/A | AP | RLD, RS | 1982-10-27 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018801-004 | STERILE WATER FOR INJECTION | 100% (50ML) | LIQUID / N/A | RLD, RS | 1982-10-27 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N018801-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N018801-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018801-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018801-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N018801-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N018801-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018801-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018801-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018801-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018801-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018801-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018801-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018801-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018801-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018801-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018801-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018801-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018801-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N018801-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N018801-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018801-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018801-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018801-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018801-003 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018801-002 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018801-003 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N018801-002 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N018801-003 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018801-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N018801-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N018801-002 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N018801-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N018801-002 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N018801-002 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018801-002 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N018801-002 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N018801-002 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N018801-002 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N018801-002 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N018801-001 | AP | 1 | b00525d2431f… |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71872-7041-1 | Sterile Water | 50 mL in 1 VIAL, PLASTIC | INJECTION | 50 | 2 | |
| 71872-7041-1 | Sterile Water | 1 in 1 BAG | INJECTION | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71872-7041 | STERILE WATER (WATER) INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20190212_81a1a49e-fd89-59d8-e053-2a91aa0ac3c3.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sterile Water | WATER | Cardinal Health 107, LLC | 9655cd02-82b5-4a75-813b-854b19551481 | 2026-07-21 | Warnings, Adverse reactions | 018801 NDA018801 |
| Sterile Water | WATER | Hospira, Inc. | 3a6422e1-feee-4095-8883-2b0837039e6e | 2026-05-07 | Warnings, Adverse reactions | 018801 NDA018801 |
| Sterile Water | WATER | Hospira, Inc. | 2b9ea23a-f9e9-48a8-25b7-519e3bbd6828 | 2026-03-18 | Warnings, Adverse reactions | 018801 NDA018801 |
| Sterile Water | WATER | ProPharma Distribution | 386a0a2f-4ff7-f128-e063-6294a90a7d4d | 2025-12-18 | Warnings, Adverse reactions | 018801 NDA018801 |
| STERILE WATER | WATER | Henry Schein, Inc. | f4087143-9868-4308-b96c-43657ee8ec28 | 2025-11-07 | Warnings, Adverse reactions | 018801 NDA018801 |
| Sterile Water | WATER | Henry Schein, Inc. | 88403fcf-a276-42c0-88b6-bd84a720b564 | 2025-05-29 | Warnings, Adverse reactions | 018801 NDA018801 |
| STERILE WATER | STERILE WATER | HF Acquisition Co. LLC, DBA HealthFirst | 74ed2a6f-824c-a1ff-e053-2a91aa0a57c0 | 2025-01-09 | Warnings, Adverse reactions | 018801 NDA018801 |
| STERILE WATER | STERILE WATER | HF Acquisition Co LLC, DBA HealthFirst | 77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b83 | 2025-01-09 | Warnings, Adverse reactions | 018801 NDA018801 |
| STERILE WATER | STERILE WATER | HF Acquisition Co LLC, DBA HealthFirst | 7610bf80-61b7-982f-e053-2a91aa0ac1bb | 2025-01-09 | Warnings, Adverse reactions | 018801 NDA018801 |
| STERILE WATER | STERILE WATER | HF Acquisition Co LLC, DBA HealthFirst | 99b1cb12-0b2d-0c0f-e053-2a95a90ac3b6 | 2025-01-08 | Warnings, Adverse reactions | 018801 NDA018801 |
| Sterile Water | WATER | A-S Medication Solutions | dba87371-31d2-47c2-ab83-89aabce4b184 | 2024-01-31 | Warnings, Adverse reactions | 018801 NDA018801 |
| Sterile Water | WATER | Medical Purchasing Solutions, LLC | e90b47e3-9636-b9ee-e053-2a95a90ad48c | 2022-09-19 | Warnings, Adverse reactions | 018801 NDA018801 |
| Sterile Water | WATER | Asclemed USA, Inc. | 45c38269-883c-4198-a9d5-03810a4420ec | 2021-01-14 | Warnings, Adverse reactions | 018801 NDA018801 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 71872-7041-1 | 71872704101 | 1 VIAL, PLASTIC in 1 BAG (71872-7041-1) / 50 mL in 1 VIAL, PLASTIC | 2019-01-07 | 0000-00-00 | No | No | Current |