Sterile Water
- Product NDC
- 52584-887
- 11-digit product format
- 525840887
- Labeler code
- 52584
- Product ID
- 52584-887_f32269cf-a827-4c15-9345-6855f5649a7a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Water
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- General Injectables & Vaccines, Inc
- Application
- NDA018801
- Marketing category
- NDA
- Marketing start
- 2010-03-01
- Marketing end
- 0000-00-00
- Substance
- WATER
- Active strength
- 1 mL/mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 52584-887 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 52584-887 | 52584-887-10 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 52584-887 | 52584-887-20 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 52584-887 | 52584-887-50 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 52584-887 | 52584-887-99 | D | Discontinued by firm | 2026-08-11 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52584-887-50 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52584-887-99 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52584-887-20 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 52584-887-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52584-887-50 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52584-887-99 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52584-887-20 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 52584-887-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52584-887-99 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 52584-887-20 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52584-887-99 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 52584-887-20 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52584-887-99 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 52584-887-20 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52584-887-99 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 52584-887-20 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52584-887-99 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 52584-887-20 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52584-887-99 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 52584-887-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52584-887-99 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 52584-887-20 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 52584-887-99 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 52584-887-99 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 52584-887-99 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Water | ACTIVE INGREDIENT | 059QF0KO0R | STERILE WATER (WATER) SOLUTION [GENERAL INJECTABLES & VACCINES, INC] | 3 | |
| Water | ACTIVE MOIETY | 059QF0KO0R | STERILE WATER (WATER) SOLUTION [GENERAL INJECTABLES & VACCINES, INC] | 3 |
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 |
|---|---|---|---|---|---|---|---|
| 52584-887-10 | 52584088710 | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-887-10) > 10 mL in 1 VIAL, SINGLE-DOSE | 2016-07-20 | 0000-00-00 | No | No | Current |
| 52584-887-20 | 52584088720 | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-887-20) > 20 mL in 1 VIAL, SINGLE-DOSE | 2016-07-20 | 0000-00-00 | No | No | Current |
| 52584-887-50 | 52584088750 | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-887-50) > 50 mL in 1 VIAL, SINGLE-DOSE | 2016-07-20 | 0000-00-00 | No | No | Current |