Ciprofloxacin in Dextrose
- Product NDC
- 0409-2300
- 11-digit product format
- 004092300
- Labeler code
- 0409
- Product ID
- 0409-2300_c63c8728-adee-439d-a634-07ce0a373093
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ciprofloxacin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA078252
- Marketing category
- ANDA
- Marketing start
- 2023-06-30
- Substance
- CIPROFLOXACIN
- Active strength
- 200 mg/100mL
- Pharmacologic classes
- Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
- 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 |
|---|---|---|---|---|---|---|---|
| A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CIPROFLOXACIN | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | |
| A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | CIPROFLOXACIN | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078252-001 | AP |
| A078252-002 | 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 | A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078252-001 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 200MG/100ML | INJECTABLE / INJECTION | AP | 2008-03-18 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A078252-002 | CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | 400MG/200ML | INJECTABLE / INJECTION | AP | 2008-03-18 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078252-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078252-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078252-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078252-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078252-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078252-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078252-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078252-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078252-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078252-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078252-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078252-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078252-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078252-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078252-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078252-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078252-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078252-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078252-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078252-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078252-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078252-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078252-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078252-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078252-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078252-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078252-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078252-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078252-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A078252-002 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078252-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078252-002 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078252-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078252-002 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078252-001 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078252-002 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078252-001 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078252-002 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A078252-001 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078252-002 | AP | 1 | bb7c543d1eb4… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ciprofloxacin in Dextrose
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CIPROFLOXACIN | 200 mg/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5E8K9I0O4U | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| cbbbf939-3219-4515-a48e-ca264daa4d07 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0409-2300-01 | Ciprofloxacin in Dextrose | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | 7 | |
| 0409-2300-01 | Ciprofloxacin in Dextrose | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | 7 | |
| 0409-2300-24 | Ciprofloxacin in Dextrose | 24 in 1 CARTON | INJECTION, SOLUTION | 24 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0409-2300-01 | ML - Milliliter | 0409-2300 | bbde010e-3ec1-4e61-964a-3e2a5abdf86e | 1 | 2023-08-08 |
| 0409-2300-24 | ML - Milliliter | 0409-2300 | 9db173b6-31e7-411d-8204-15ee9d7568c0 | 1 | 2023-07-06 |
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 |
|---|---|---|---|---|---|---|
| Ciprofloxacin in Dextrose | CIPROFLOXACIN | ProPharma Distribution | 42c758be-4d44-018a-e063-6294a90ae041 | 2025-11-04 | Boxed warning, Warnings, Adverse reactions | 078252 ANDA078252 |
| Ciprofloxacin in Dextrose | CIPROFLOXACIN | Hospira, Inc. | cbbbf939-3219-4515-a48e-ca264daa4d07 | 2025-11-04 | Boxed warning, Warnings, Adverse reactions | 078252 ANDA078252 0409-2300 |
| Ciprofloxacin | CIPROFLOXACIN | Sagent Pharmaceuticals | 7049f870-6741-4a67-8033-398c36126a06 | 2022-09-19 | Boxed warning, Warnings, Adverse reactions | 078252 ANDA078252 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1665210 | ciprofloxacin 200 MG in 100 ML Injection | PSN | cbbbf939-3219-4515-a48e-ca264daa4d07 | 7 |
| 1665212 | ciprofloxacin 400 MG in 200 ML Injection | PSN | cbbbf939-3219-4515-a48e-ca264daa4d07 | 7 |
| 1665210 | 100 ML ciprofloxacin 2 MG/ML Injection | SCD | cbbbf939-3219-4515-a48e-ca264daa4d07 | 7 |
| 1665212 | 200 ML ciprofloxacin 2 MG/ML Injection | SCD | cbbbf939-3219-4515-a48e-ca264daa4d07 | 7 |
| 1665210 | ciprofloxacin 200 MG per 100 ML Injection | SY | cbbbf939-3219-4515-a48e-ca264daa4d07 | 7 |
| 1665212 | ciprofloxacin 400 MG per 200 ML Injection | SY | cbbbf939-3219-4515-a48e-ca264daa4d07 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0409-2300-01 | 00409230001 | 1 in 1 POUCH | Historical | |||||
| 0409-2300-24 | 00409230024 | 24 POUCH in 1 CARTON (0409-2300-24) / 1 BAG in 1 POUCH (0409-2300-01) / 100 mL in 1 BAG | 24 pouch | 2023-06-30 | 0000-00-00 | No | No | Current |