NDC 0338-0043 – Sodium Chloride
Sodium Chloride 4.5 g/1000mL · Injection, Solution · Intravenous
Product NDC0338-0043
Product details
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Labeler
- Baxter Healthcare Corporation
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Marketing category
- NDA · NDA018016
- Marketed since
- February 2, 1979
- Listing expires
- December 31, 2027
- Pharmacologic class
- Osmotic Laxative
Active ingredients
- Sodium Chloride 4.5 g/1000mL
Uses, dosage, side effects and warnings for Sodium Chloride →
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 0338-0043-03 | 500 mL in 1 BAG (0338-0043-03) | Feb 2, 1979 |
| 0338-0043-04 | 1000 mL in 1 BAG (0338-0043-04) | Feb 2, 1979 |
Recalls mentioning this NDC
- D-0849-2026 Sep 9, 2026 · Class I
Presence of particulate matter: Particulates identified as fiberglass - D-1514-2019 Jul 31, 2019 · Class II
Lack of Assurance of Sterility: Bags have potential to leak. - D-1190-2018 Sep 26, 2018 · Class II
cGMP Deviation - D-1128-2018 Sep 5, 2018 · Class II
CGMP Deviations - D-0973-2017 Jul 19, 2017 · Class II
Lack of Assurance of Sterility: Bags have the potential to leak. - D-0957-2017 Jul 19, 2017 · Class II
Lack of Assurance of Sterility: Customer complaints for leaking bags. - D-0957-2016 Jun 15, 2016 · Class I
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product. - D-1816-2015 Sep 30, 2015 · Class II
Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch. - D-1336-2015 Aug 26, 2015 · Class I
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled. - D-1326-2015 Aug 19, 2015 · Class II
Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.
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- 0264-1800 Sodium Chloride 9 mg/mL · Injection, Solution · B. Braun Medical Inc.
- 0264-5802 Sodium Chloride .9 g/100mL · Injection, Solution · B. Braun Medical Inc.
- 0264-5804 Sodium Chloride .45 g/100mL · Injection, Solution · B. Braun Medical Inc.
- 0264-7800 Sodium Chloride .9 g/100mL · Injection, Solution · B. Braun Medical Inc.
- 0264-7802 Sodium Chloride .45 g/100mL · Injection, Solution · B. Braun Medical Inc.
- 0264-7805 Sodium Chloride 3 g/100mL · Injection, Solution · B. Braun Medical Inc.
- 0264-7806 Sodium Chloride 5 g/100mL · Injection, Solution · B. Braun Medical Inc.
- 0338-0054 Sodium Chloride 3 g/100mL · Injection, Solution · Baxter Healthcare Corporation
- 0338-9657 Sodium Chloride 9 g/1000mL · Injection, Solution · Baxter Healthcare Corporation
- 0338-0056 Sodium Chloride 5 g/100mL · Injection, Solution · Baxter Healthcare Corporation
- 0338-0049 Sodium Chloride 9 g/1000mL · Injection, Solution · Baxter Healthcare Corporation