Sodium Chloride
- Product NDC
- 0264-9375
- 11-digit product format
- 002649375
- Labeler code
- 0264
- Product ID
- 0264-9375_7a6642e8-d304-47fc-acd9-0dcac4650f88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Chloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- B. Braun Medical Inc.
- Application
- NDA019635
- Marketing category
- NDA
- Marketing start
- 2016-08-09
- Substance
- SODIUM CHLORIDE
- Active strength
- 9 mg/mL
- Pharmacologic classes
- Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019635-001 | SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 450MG/100ML | INJECTABLE / INJECTION | AP | RLD | 1988-03-09 |
| N019635-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 900MG/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-03-09 |
| N019635-003 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 3GM/100ML | INJECTABLE / INJECTION | AP | 1988-03-09 | |
| N019635-004 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 5GM/100ML | INJECTABLE / INJECTION | AP | 1988-03-09 | |
| N019635-005 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 2016-08-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N019635-001 | AP |
| N019635-002 | AP |
| N019635-003 | AP |
| N019635-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N019635-001 | SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 450MG/100ML | INJECTABLE / INJECTION | AP | RLD | 1988-03-09 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019635-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-03-09 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019635-003 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | 1988-03-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019635-004 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | 1988-03-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019635-005 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 2016-08-08 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019635-001 | SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 450MG/100ML | INJECTABLE / INJECTION | AP | RLD | 1988-03-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019635-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-03-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019635-003 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | 1988-03-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019635-004 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | 1988-03-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019635-005 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 2016-08-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019635-001 | SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 450MG/100ML | INJECTABLE / INJECTION | AP | RLD | 1988-03-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019635-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-03-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019635-003 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | 1988-03-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019635-004 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | 1988-03-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019635-005 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 2016-08-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019635-001 | SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 450MG/100ML | INJECTABLE / INJECTION | AP | RLD | 1988-03-09 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019635-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-03-09 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019635-003 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | 1988-03-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019635-004 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | 1988-03-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019635-005 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 2016-08-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019635-001 | SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 450MG/100ML | INJECTABLE / INJECTION | AP | RLD | 1988-03-09 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019635-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-03-09 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019635-003 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | 1988-03-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019635-004 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | 1988-03-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019635-005 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 2016-08-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019635-001 | SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 450MG/100ML | INJECTABLE / INJECTION | AP | RLD | 1988-03-09 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019635-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-03-09 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019635-003 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | 1988-03-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019635-004 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | 1988-03-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019635-005 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 2016-08-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019635-001 | SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 450MG/100ML | INJECTABLE / INJECTION | AP | RLD | 1988-03-09 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019635-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-03-09 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019635-003 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | 1988-03-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019635-004 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | 1988-03-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019635-005 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 2016-08-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019635-001 | SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 450MG/100ML | INJECTABLE / INJECTION | AP | RLD | 1988-03-09 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019635-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 900MG/100ML | INJECTABLE / INJECTION | AP | RLD, RS | 1988-03-09 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019635-003 | SODIUM CHLORIDE 3% IN PLASTIC CONTAINER | 3GM/100ML | INJECTABLE / INJECTION | AP | 1988-03-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019635-004 | SODIUM CHLORIDE 5% IN PLASTIC CONTAINER | 5GM/100ML | INJECTABLE / INJECTION | AP | 1988-03-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019635-005 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | RLD | 2016-08-08 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N019635-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019635-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019635-003 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N019635-004 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N019635-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019635-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019635-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N019635-004 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019635-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019635-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019635-003 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019635-004 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N019635-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019635-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019635-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N019635-004 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019635-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019635-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019635-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019635-004 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019635-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019635-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019635-003 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019635-004 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019635-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019635-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019635-003 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019635-004 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019635-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019635-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019635-003 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019635-004 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019635-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019635-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019635-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019635-004 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019635-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019635-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019635-003 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019635-004 | AP | 1 | d8e5a09893c0… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sodium Chloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM CHLORIDE | 9 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 451W47IQ8X | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1807637 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 24a08a93-df23-474b-873e-c59ec8855f9f | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0264-9375-88 | 2022-03-14 | C162847 | 48780-1 | d6a99b39-4efd-a426-e053-dadaa90af4c2 | 0.9% Sodium Chloride Injection USP |
| 0264-9375-88 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-4efd-a426-e053-dadaa90af4c2 | 0.9% Sodium Chloride Injection USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0264-9375-88 | Sodium Chloride | 10 mL in 1 AMPULE | INJECTION | 10 | 8 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | 47a0313f-36df-4fa6-a828-c9e1946ba9b0 | 2024-05-08 | Warnings, Adverse reactions | 019635 NDA019635 |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | 7f22c06b-6b4d-4b49-a4b2-d2169f2bd653 | 2024-05-07 | Warnings, Adverse reactions | 019635 NDA019635 |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | f2475fa3-ab1d-4b81-8127-b58cd0790a54 | 2024-05-06 | Warnings, Adverse reactions | 019635 NDA019635 |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | 24a08a93-df23-474b-873e-c59ec8855f9f | 2022-03-14 | Warnings, Adverse reactions | 019635 NDA019635 0264-9375 |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | e44c41ae-c9c8-4dd8-ba6c-cebb585378aa | 2022-01-31 | Warnings, Adverse reactions | 019635 NDA019635 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1807637 | sodium chloride 0.9 % in 10 ML Injection | PSN | 24a08a93-df23-474b-873e-c59ec8855f9f | 8 |
| 1807637 | 10 ML sodium chloride 9 MG/ML Injection | SCD | 24a08a93-df23-474b-873e-c59ec8855f9f | 8 |
| 1807637 | 10 ML NaCl 9 MG/ML Injection | SY | 24a08a93-df23-474b-873e-c59ec8855f9f | 8 |
| 1807637 | normal saline 10 mL Injection | SY | 24a08a93-df23-474b-873e-c59ec8855f9f | 8 |
| 1807637 | sodium chloride 0.9 % per 10 ML Injection | SY | 24a08a93-df23-474b-873e-c59ec8855f9f | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0264-9375-88 | 00264937588 | 10 mL in 1 AMPULE (0264-9375-88) | 10 ml | 2016-08-09 | 0000-00-00 | No | No | Current |