Ciprofloxacin Hydrochloride
- Product NDC
- 21695-259
- 11-digit product format
- 216950259
- Labeler code
- 21695
- Product ID
- 21695-259_2ef01a91-e73e-46d6-a6f9-d7d6dae91ea2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ciprofloxacin hydrochloride
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Rebel Distributors Corp
- Application
- NDA019992
- Marketing category
- NDA
- Marketing start
- 1990-12-31
- Marketing end
- 0000-00-00
- Substance
- CIPROFLOXACIN HYDROCHLORIDE
- Active strength
- 4 mg/mL
- Pharmacologic classes
- Quinolone Antimicrobial [EPC],Quinolones [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-259-05 | 2019-09-24 | C162847 | 48780-1 | 934fe258-49ef-48b1-e053-8cdaa90a720a | CIPROFLOXACIN HYDROCHLORIDE OPHTHALMIC SOLUTION 0.3% as base Sterile |
| 21695-259-10 | 2019-09-24 | C162847 | 48780-1 | 934fe258-49ef-48b1-e053-8cdaa90a720a | CIPROFLOXACIN HYDROCHLORIDE OPHTHALMIC SOLUTION 0.3% as base Sterile |
| 21695-259-25 | 2019-09-24 | C162847 | 48780-1 | 934fe258-49ef-48b1-e053-8cdaa90a720a | CIPROFLOXACIN HYDROCHLORIDE OPHTHALMIC SOLUTION 0.3% as base Sterile |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-259-05 | Ciprofloxacin Hydrochloride | 5 mL in 1 BOTTLE, PLASTIC | SOLUTION | 5 | 1 | |
| 21695-259-10 | Ciprofloxacin Hydrochloride | 10 mL in 1 BOTTLE, PLASTIC | SOLUTION | 10 | 1 | |
| 21695-259-25 | Ciprofloxacin Hydrochloride | 2.5 mL in 1 BOTTLE, PLASTIC | SOLUTION | 2.5 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-259-05 | ML - Milliliter | 21695-259 | 19c0742b-0422-4457-8044-5520832e1bb2 | 1 | 2012-07-24 |
| 21695-259-10 | ML - Milliliter | 21695-259 | 14ad3bba-3833-4fb5-888c-caed2966eaa6 | 1 | 2012-07-24 |
| 21695-259-25 | ML - Milliliter | 21695-259 | b2503998-4631-411e-ab70-0afd67b447b7 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ciprofloxacin hydrochloride | ACTIVE INGREDIENT | 4BA73M5E37 | CIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| ciprofloxacin | ACTIVE MOIETY | 5E8K9I0O4U | CIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| acetic acid | INACTIVE INGREDIENT | Q40Q9N063P | CIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | CIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | CIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | CIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| sodium acetate | INACTIVE INGREDIENT | 4550K0SC9B | CIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | CIPROFLOXACIN HYDROCHLORIDE SOLUTION [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309307 | ciprofloxacin HCl 0.3 % Ophthalmic Solution | PSN | 2ef01a91-e73e-46d6-a6f9-d7d6dae91ea2 | 1 |
| 309307 | ciprofloxacin 3 MG/ML Ophthalmic Solution | SCD | 2ef01a91-e73e-46d6-a6f9-d7d6dae91ea2 | 1 |
| 309307 | ciprofloxacin 0.3 % Ophthalmic Solution | SY | 2ef01a91-e73e-46d6-a6f9-d7d6dae91ea2 | 1 |
| 309307 | ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution | SY | 2ef01a91-e73e-46d6-a6f9-d7d6dae91ea2 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 21695-259-05 | 21695025905 | 5 mL in 1 BOTTLE, PLASTIC | 5 ml | Historical |
| 21695-259-10 | 21695025910 | 10 mL in 1 BOTTLE, PLASTIC | 10 ml | Historical |
| 21695-259-25 | 21695025925 | 2.5 mL in 1 BOTTLE, PLASTIC | 2.5 ml | Historical |