Sterile Water
- Product NDC
- 64253-020
- 11-digit product format
- 642530020
- Labeler code
- 64253
- Product ID
- 64253-020_2b39b41d-419a-dab8-e063-6394a90a319a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sterile Water for Injection
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Medefil, Inc.
- Application
- ANDA211188
- Marketing category
- ANDA
- Marketing start
- 2020-01-27
- Substance
- WATER
- Active strength
- 100 mL/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sterile Water
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| WATER | 100 mL/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 059QF0KO0R |
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 64253-020-21 | 2022-02-04 | C162847 | 48780-1 | d6a99b39-7add-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019 |
| 64253-020-23 | 2022-02-04 | C162847 | 48780-1 | d6a99b39-7add-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019 |
| 64253-020-25 | 2022-02-04 | C162847 | 48780-1 | d6a99b39-7add-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019 |
| 64253-020-30 | 2022-02-04 | C162847 | 48780-1 | d6a99b39-7add-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019 |
| 64253-020-35 | 2022-02-04 | C162847 | 48780-1 | d6a99b39-7add-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019 |
| 64253-020-52 | 2022-02-04 | C162847 | 48780-1 | d6a99b39-7add-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019 |
| 64253-020-91 | 2022-02-04 | C162847 | 48780-1 | d6a99b39-7add-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019 |
| 64253-020-21 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-7add-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019 |
| 64253-020-23 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-7add-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019 |
| 64253-020-25 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-7add-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019 |
| 64253-020-30 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-7add-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019 |
| 64253-020-35 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-7add-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019 |
| 64253-020-52 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-7add-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019 |
| 64253-020-91 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-7add-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use STERILE WATER FOR INJECTION, USP safely and effectively. See full prescribing information for STERILE WATER FOR INJECTION, USP. STERILE WATER FOR INJECTION, USP for Intravenous, Intramuscular, and Subcutaneous Injection Initial U.S. Approval: 2019 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64253-020-21 | Sterile Water | 1 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 1 | | 5 |
| 64253-020-21 | Sterile Water | 60 in 1 BOX | INJECTION, SOLUTION | 60 | | 5 |
| 64253-020-23 | Sterile Water | 3 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 3 | | 5 |
| 64253-020-23 | Sterile Water | 60 in 1 BOX | INJECTION, SOLUTION | 60 | | 5 |
| 64253-020-25 | Sterile Water | 5 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 5 | | 5 |
| 64253-020-25 | Sterile Water | 60 in 1 BOX | INJECTION, SOLUTION | 60 | | 5 |
| 64253-020-30 | Sterile Water | 60 in 1 BOX | INJECTION, SOLUTION | 60 | | 5 |
| 64253-020-30 | Sterile Water | 10 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 10 | | 5 |
| 64253-020-35 | Sterile Water | 60 in 1 BOX | INJECTION, SOLUTION | 60 | | 5 |
| 64253-020-35 | Sterile Water | 5 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 5 | | 5 |
| 64253-020-52 | Sterile Water | 60 in 1 BOX | INJECTION, SOLUTION | 60 | | 5 |
| 64253-020-52 | Sterile Water | 2.5 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 2.5 | | 5 |
| 64253-020-91 | Sterile Water | 10 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 10 | | 5 |
| 64253-020-91 | Sterile Water | 10 in 1 BOX | INJECTION, SOLUTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64253-020 | STERILE WATER (STERILE WATER FOR INJECTION) INJECTION, SOLUTION [MEDEFIL, INC.] | 5 | Current NDC, Legacy NDC, 14 package rows | 20250110_99e99a50-82d5-aff6-e053-2a95a90a8c56.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 64253-020-21 | 64253002021 | 60 SYRINGE, PLASTIC in 1 BOX (64253-020-21) / 1 mL in 1 SYRINGE, PLASTIC | 2020-01-27 | 0000-00-00 | No | No | Current |
| 64253-020-23 | 64253002023 | 60 SYRINGE, PLASTIC in 1 BOX (64253-020-23) / 3 mL in 1 SYRINGE, PLASTIC | 2020-01-27 | 0000-00-00 | No | No | Current |
| 64253-020-25 | 64253002025 | 60 SYRINGE, PLASTIC in 1 BOX (64253-020-25) / 5 mL in 1 SYRINGE, PLASTIC | 2020-09-21 | 0000-00-00 | No | No | Current |
| 64253-020-30 | 64253002030 | 60 SYRINGE, PLASTIC in 1 BOX (64253-020-30) / 10 mL in 1 SYRINGE, PLASTIC | 2020-01-27 | 0000-00-00 | No | No | Current |
| 64253-020-35 | 64253002035 | 60 SYRINGE, PLASTIC in 1 BOX (64253-020-35) / 5 mL in 1 SYRINGE, PLASTIC | 2020-01-27 | 0000-00-00 | No | No | Current |
| 64253-020-52 | 64253002052 | 60 SYRINGE, PLASTIC in 1 BOX (64253-020-52) / 2.5 mL in 1 SYRINGE, PLASTIC | 2020-01-27 | 0000-00-00 | No | No | Current |
| 64253-020-91 | 64253002091 | 10 SYRINGE, PLASTIC in 1 BOX (64253-020-91) / 10 mL in 1 SYRINGE, PLASTIC | 2020-09-21 | 0000-00-00 | No | No | Current |