Sodium Chloride
- Product NDC
- 0404-9955
- 11-digit product format
- 004049955
- Labeler code
- 0404
- Product ID
- 0404-9955_1e6c9f43-8251-45d9-979a-7de12ec9ad32
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Chloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA088912
- Marketing category
- ANDA
- Marketing start
- 2022-01-12
- Substance
- SODIUM CHLORIDE
- Active strength
- 9 mg/mL
- 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 |
|---|---|---|---|---|---|---|---|
| A088912-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 |
| A088912-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 |
| A088912-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 |
| A088912-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 18MG/2ML (9MG/ML) | SOLUTION / INJECTION | RS | 1985-11-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A088912-001 | AP |
| A088912-002 | AP |
| A088912-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A088912-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A088912-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A088912-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A088912-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 18MG/2ML (9MG/ML) | SOLUTION / INJECTION | RS | 1985-11-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A088912-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A088912-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A088912-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A088912-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 18MG/2ML (9MG/ML) | SOLUTION / INJECTION | RS | 1985-11-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A088912-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A088912-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A088912-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A088912-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 18MG/2ML (9MG/ML) | SOLUTION / INJECTION | RS | 1985-11-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088912-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088912-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088912-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088912-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 18MG/2ML (9MG/ML) | SOLUTION / INJECTION | RS | 1985-11-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A088912-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A088912-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A088912-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A088912-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 18MG/2ML (9MG/ML) | SOLUTION / INJECTION | RS | 1985-11-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088912-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088912-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088912-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088912-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 18MG/2ML (9MG/ML) | SOLUTION / INJECTION | RS | 1985-11-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088912-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088912-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088912-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088912-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 18MG/2ML (9MG/ML) | SOLUTION / INJECTION | RS | 1985-11-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088912-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088912-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088912-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088912-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 18MG/2ML (9MG/ML) | SOLUTION / INJECTION | RS | 1985-11-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088912-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088912-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088912-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088912-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 18MG/2ML (9MG/ML) | SOLUTION / INJECTION | RS | 1985-11-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088912-001 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088912-002 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088912-003 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 270MG/30ML (9MG/ML) | SOLUTION / INJECTION | AP | RS | 1985-01-10 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088912-004 | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 18MG/2ML (9MG/ML) | SOLUTION / INJECTION | RS | 1985-11-29 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088912-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088912-003 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088912-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088912-002 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088912-003 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A088912-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A088912-002 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A088912-003 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A088912-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A088912-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A088912-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A088912-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A088912-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A088912-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A088912-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A088912-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A088912-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A088912-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A088912-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A088912-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A088912-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A088912-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A088912-002 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A088912-003 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A088912-001 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A088912-002 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A088912-003 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A088912-001 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A088912-002 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A088912-003 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A088912-001 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A088912-002 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A088912-003 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A088912-001 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A088912-002 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A088912-003 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A088912-001 | AP | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A088912-002 | AP | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A088912-003 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A088912-001 | AP | 1 | 3f0d92c62455… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |
|---|---|
| e0466bb3-6c26-4044-b051-69f48b67f632 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0404-9955-10 | Sodium Chloride | 1 in 1 BAG | INJECTION | 1 | 6 | |
| 0404-9955-10 | Sodium Chloride | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | 6 |
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 | Cardinal Health 107, LLC | 97007188-43fe-416c-a87b-6ccc4d9ae2ec | 2025-10-29 | Adverse reactions | 088912 ANDA088912 |
| Sodium Chloride | SODIUM CHLORIDE | Henry Schein, Inc. | e0466bb3-6c26-4044-b051-69f48b67f632 | 2025-08-07 | Adverse reactions | 088912 ANDA088912 0404-9955 |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | f62481fd-fcdb-4be6-ac13-29c590e925c3 | 2022-02-10 | Adverse reactions | 088912 ANDA088912 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1807637 | sodium chloride 0.9 % in 10 ML Injection | PSN | e0466bb3-6c26-4044-b051-69f48b67f632 | 6 |
| 1807637 | 10 ML sodium chloride 9 MG/ML Injection | SCD | e0466bb3-6c26-4044-b051-69f48b67f632 | 6 |
| 1807637 | 10 ML NaCl 9 MG/ML Injection | SY | e0466bb3-6c26-4044-b051-69f48b67f632 | 6 |
| 1807637 | normal saline 10 mL Injection | SY | e0466bb3-6c26-4044-b051-69f48b67f632 | 6 |
| 1807637 | sodium chloride 0.9 % per 10 ML Injection | SY | e0466bb3-6c26-4044-b051-69f48b67f632 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0404-9955-10 | 00404995510 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9955-10) / 10 mL in 1 VIAL, SINGLE-DOSE | 2022-01-12 | 0000-00-00 | No | No | Current |