Sterile Water
- Product NDC
- 62135-833
- 11-digit product format
- 621350833
- Labeler code
- 62135
- Product ID
- 62135-833_10594df5-e2d0-a24e-e063-6394a90afe26
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sterile Water
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Chartwell RX, LLC
- Application
- ANDA211222
- Marketing category
- ANDA
- Marketing start
- 2021-06-07
- Substance
- WATER
- Active strength
- 1 mL/mL
- 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 | 1 mL/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 059QF0KO0R |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-833-84 | Sterile Water | 30 in 1 CARTON | INJECTION | 30 | | 2 |
| 62135-833-84 | Sterile Water | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-833 | STERILE WATER INJECTION [CHARTWELL RX, LLC] | 2 | Current NDC, 2 package rows | 20240202_3681eeaa-807a-47ca-9fbc-61c2b682800a.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-833-84 | 62135083384 | 30 VIAL, SINGLE-DOSE in 1 CARTON (62135-833-84) / 5 mL in 1 VIAL, SINGLE-DOSE | 2024-01-25 | No | No | Historical |