Ciprofloxacin Hydrochloride
- Product NDC
- 33261-910
- 11-digit product format
- 332610910
- Labeler code
- 33261
- Product ID
- 33261-910_1feb09ed-35ba-4e97-8198-bfc979767f4c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ciprofloxacin Hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- NDA019992
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2018-04-03
- 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
- 2019-12-31
- 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 |
|---|---|---|---|---|---|
| 33261-910-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-0b11-f424-e053-dadaa90a57ce | Ciprofloxacin Hydrochloride Ophthalmic Solution 0.3% as base Sterile |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33261-910-01 | Ciprofloxacin Hydrochloride | 2.5 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 2.5 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 33261-910-01 | ML - Milliliter | 33261-910 | 6b0acfb8-5a47-4a1a-9a21-325b41e5fb00 | 1 | 2018-09-05 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309307 | ciprofloxacin HCl 0.3 % Ophthalmic Solution | PSN | d88a73c8-24d6-433e-a2c3-69b91e7be96a | 1 |
| 309307 | ciprofloxacin 3 MG/ML Ophthalmic Solution | SCD | d88a73c8-24d6-433e-a2c3-69b91e7be96a | 1 |
| 309307 | ciprofloxacin 0.3 % Ophthalmic Solution | SY | d88a73c8-24d6-433e-a2c3-69b91e7be96a | 1 |
| 309307 | ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution | SY | d88a73c8-24d6-433e-a2c3-69b91e7be96a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 33261-910-01 | 33261091001 | 2.5 mL in 1 BOTTLE, PLASTIC | 2.5 ml | Historical |