Ciprofloxacin Hydrochloride
- Product NDC
- 50436-0656
- 11-digit product format
- 504360656
- Labeler code
- 50436
- Product ID
- 50436-0656_d9151dbb-c80a-4460-9639-bcae776e0f3f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ciprofloxacin Hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Unit Dose Services
- Application
- NDA019992
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2004-05-07
- Marketing end
- 0000-00-00
- Substance
- CIPROFLOXACIN HYDROCHLORIDE
- Active strength
- 3 mg/mL
- Pharmacologic classes
- Quinolone Antimicrobial [EPC],Quinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ea50b939-d92a-4100-84f5-1c1089663837 | Product name | 2 | 20240705 |
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 90aab9f8-63f3-478d-8db8-951525a18ab1 | Product name | 1 | 20180814 |
| 200e1d3d-46da-4371-beed-747da3cb3ff8 | Product name | 1 | 20180702 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| 9e453f34-aacb-44d5-a119-c0e3dc1fca2a | Product name | 1 | 20160622 |
| 01eecbfe-0b50-413b-8898-6905c89b6568 | Product name | 1 | 20151228 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| a3304bb6-ef4e-06df-d604-35f7e883ed6c | Product name | 1 | 20140508 |
| abaf203f-619e-f265-559f-8c81af5cb1c2 | Product name | 1 | 20140508 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
| de5ea793-ffd9-0308-b0ca-00d9967be4ee | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50436-0656-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-41df-a910-e053-dadaa90a0b85 | Ciprofloxacin Hydrochloride Ophthalmic Solution 0.3% as base Sterile |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-0656-1 | Ciprofloxacin Hydrochloride | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | 2 | |
| 50436-0656-1 | Ciprofloxacin Hydrochloride | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-0656 | CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) SOLUTION/ DROPS [UNIT DOSE SERVICES] | 2 | Legacy NDC, 2 package rows | 20180810_e1c02ef2-c0af-48da-aa52-3a494aa357ea.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309307 | ciprofloxacin HCl 0.3 % Ophthalmic Solution | PSN | e1c02ef2-c0af-48da-aa52-3a494aa357ea | 2 |
| 309307 | ciprofloxacin 3 MG/ML Ophthalmic Solution | SCD | e1c02ef2-c0af-48da-aa52-3a494aa357ea | 2 |
| 309307 | ciprofloxacin 0.3 % Ophthalmic Solution | SY | e1c02ef2-c0af-48da-aa52-3a494aa357ea | 2 |
| 309307 | ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution | SY | e1c02ef2-c0af-48da-aa52-3a494aa357ea | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 50436-0656-1 | 50436065601 | 5 mL in 1 BOTTLE | 5 ml | Historical |