Application 019631
- Type
- NDA
- Sponsor
- B BRAUN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 2.5GM/100ML;110MG/100ML | No | No |
| 002 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 2.5GM/100ML;200MG/100ML | No | No |
| 003 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 2.5GM/100ML;330MG/100ML | No | No |
| 004 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 2.5GM/100ML;450MG/100ML | No | No |
| 005 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 2.5GM/100ML;900MG/100ML | No | No |
| 006 | DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;110MG/100ML | No | No |
| 007 | DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;200MG/100ML | No | No |
| 008 | DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;330MG/100ML | No | No |
| 009 | DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;450MG/100ML | No | No |
| 010 | DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 5GM/100ML;900MG/100ML | No | No |
| 011 | DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 10GM/100ML;110MG/100ML | No | No |
| 012 | DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 10GM/100ML;200MG/100ML | No | No |
| 013 | DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 10GM/100ML;330MG/100ML | No | No |
| 014 | DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 10GM/100ML;450MG/100ML | No | No |
| 015 | DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 10GM/100ML;900MG/100ML | No | No |
| 016 | DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | INJECTABLE;INJECTION | 3.3GM/100ML;300MG/100ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019631-001 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 2.5GM/100ML;110MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | ||
| N019631-002 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 2.5GM/100ML;200MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | ||
| N019631-003 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 2.5GM/100ML;330MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | ||
| N019631-004 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 2.5GM/100ML;450MG/100ML | INJECTABLE / INJECTION | AP | 1988-02-24 | |
| N019631-005 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 2.5GM/100ML;900MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | ||
| N019631-006 | DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;110MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | ||
| N019631-007 | DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;200MG/100ML | INJECTABLE / INJECTION | AP | 1988-02-24 | |
| N019631-008 | DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;330MG/100ML | INJECTABLE / INJECTION | AP | 1988-02-24 | |
| N019631-009 | DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;450MG/100ML | INJECTABLE / INJECTION | AP | 1988-02-24 | |
| N019631-010 | DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 5GM/100ML;900MG/100ML | INJECTABLE / INJECTION | AP | 1988-02-24 | |
| N019631-011 | DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 10GM/100ML;110MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | ||
| N019631-012 | DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 10GM/100ML;200MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | ||
| N019631-013 | DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 10GM/100ML;330MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | ||
| N019631-014 | DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 10GM/100ML;450MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | ||
| N019631-015 | DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 10GM/100ML;900MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | ||
| N019631-016 | DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | DEXTROSE; SODIUM CHLORIDE | 3.3GM/100ML;300MG/100ML | INJECTABLE / INJECTION | 1990-01-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N019631-004 | AP |
| N019631-007 | AP |
| N019631-008 | AP |
| N019631-009 | AP |
| N019631-010 | 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 | N019631-001 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | 2.5GM/100ML;110MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019631-002 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | 2.5GM/100ML;200MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019631-003 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | 2.5GM/100ML;330MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019631-004 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 2.5GM/100ML;450MG/100ML | INJECTABLE / INJECTION | AP | 1988-02-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019631-005 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 2.5GM/100ML;900MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019631-006 | DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | 5GM/100ML;110MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019631-007 | DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | 5GM/100ML;200MG/100ML | INJECTABLE / INJECTION | AP | 1988-02-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019631-008 | DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | 5GM/100ML;330MG/100ML | INJECTABLE / INJECTION | AP | 1988-02-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019631-009 | DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5GM/100ML;450MG/100ML | INJECTABLE / INJECTION | AP | 1988-02-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019631-010 | DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;900MG/100ML | INJECTABLE / INJECTION | AP | 1988-02-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019631-011 | DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | 10GM/100ML;110MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019631-012 | DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | 10GM/100ML;200MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019631-013 | DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | 10GM/100ML;330MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019631-014 | DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 10GM/100ML;450MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019631-015 | DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 10GM/100ML;900MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019631-016 | DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | 3.3GM/100ML;300MG/100ML | INJECTABLE / INJECTION | 1990-01-19 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019631-001 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | 2.5GM/100ML;110MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019631-002 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | 2.5GM/100ML;200MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019631-003 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | 2.5GM/100ML;330MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019631-004 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 2.5GM/100ML;450MG/100ML | INJECTABLE / INJECTION | AP | 1988-02-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019631-005 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 2.5GM/100ML;900MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019631-006 | DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | 5GM/100ML;110MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019631-007 | DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | 5GM/100ML;200MG/100ML | INJECTABLE / INJECTION | AP | 1988-02-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019631-008 | DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | 5GM/100ML;330MG/100ML | INJECTABLE / INJECTION | AP | 1988-02-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019631-009 | DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 5GM/100ML;450MG/100ML | INJECTABLE / INJECTION | AP | 1988-02-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019631-010 | DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 5GM/100ML;900MG/100ML | INJECTABLE / INJECTION | AP | 1988-02-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019631-011 | DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | 10GM/100ML;110MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019631-012 | DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | 10GM/100ML;200MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019631-013 | DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | 10GM/100ML;330MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019631-014 | DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 10GM/100ML;450MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019631-015 | DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 10GM/100ML;900MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019631-016 | DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER | 3.3GM/100ML;300MG/100ML | INJECTABLE / INJECTION | 1990-01-19 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019631-001 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | 2.5GM/100ML;110MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019631-002 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | 2.5GM/100ML;200MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019631-003 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | 2.5GM/100ML;330MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019631-004 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER | 2.5GM/100ML;450MG/100ML | INJECTABLE / INJECTION | AP | 1988-02-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019631-005 | DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | 2.5GM/100ML;900MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019631-006 | DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER | 5GM/100ML;110MG/100ML | INJECTABLE / INJECTION | 1988-02-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019631-007 | DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER | 5GM/100ML;200MG/100ML | INJECTABLE / INJECTION | AP | 1988-02-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019631-008 | DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER | 5GM/100ML;330MG/100ML | INJECTABLE / INJECTION | AP | 1988-02-24 | 011fe1cb6892… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2020-12-22 03:56 UTC | 2020-12 | N019631-004 | AP | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N019631-007 | AP | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N019631-008 | AP | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N019631-009 | AP | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N019631-010 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N019631-004 | AP | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N019631-007 | AP | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N019631-008 | AP | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N019631-009 | AP | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N019631-010 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N019631-004 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N019631-007 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N019631-008 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N019631-009 | AP | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N019631-010 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N019631-004 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N019631-007 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N019631-008 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N019631-009 | AP | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N019631-010 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N019631-004 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N019631-007 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N019631-008 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N019631-009 | AP | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N019631-010 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019631-004 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019631-007 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019631-008 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019631-009 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019631-010 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N019631-004 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N019631-007 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N019631-008 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N019631-009 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N019631-010 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N019631-004 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N019631-007 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N019631-008 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N019631-009 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N019631-010 | AP | 1 | ea1830bbd6c7… |
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 |
|---|---|---|---|---|---|---|
| Dextrose And Sodium Chloride | DEXTROSE AND SODIUM CHLORIDE | B. Braun Medical Inc. | 8e6569ce-9714-497f-a94b-c6975c1d76f6 | 2024-04-02 | Warnings, Adverse reactions | 019631 NDA019631 0264-7605 0264-7614 0264-7612 0264-7622 0264-7610 0264-7616 0264-7608 0264-7623 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0264-7605 | Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7608 | Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7608 | Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7610 | Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7610 | Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7612 | Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7612 | Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7614 | Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7614 | Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7616 | Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7616 | Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7622 | Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7622 | Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7623 | Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |
| 0264-7623 | Dextrose And Sodium Chloride | DEXTROSE and SODIUM CHLORIDE | B. Braun Medical Inc. | NDA | Current |