CIPROFLOXACIN
- Product NDC
- 61919-795
- 11-digit product format
- 619190795
- Labeler code
- 61919
- Product ID
- 61919-795_f215bd63-381c-508b-e053-2a95a90aaa48
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CIPROFLOXACIN
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Direct_Rx
- Application
- ANDA077568
- Marketing category
- ANDA
- Marketing start
- 2019-07-23
- 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
- 2024-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a21a21e5-f36d-4c1f-8918-def921b8f7e3 | Product name | 3 | 20250124 |
| ea50b939-d92a-4100-84f5-1c1089663837 | Product name | 2 | 20240705 |
| 777d68c6-a5ab-e06c-d314-677b0b9af0c8 | Product name | 2 | 20240508 |
| 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 |
| a3304bb6-ef4e-06df-d604-35f7e883ed6c | Product name | 1 | 20140508 |
| abaf203f-619e-f265-559f-8c81af5cb1c2 | 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 |
|---|---|---|---|---|---|
| 61919-795-05 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5ca6-d83d-e063-dadaa90ab31f | CIPROFLOXACIN |
| 61919-795-25 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5ca6-d83d-e063-dadaa90ab31f | CIPROFLOXACIN |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-795-05 | CIPROFLOXACIN | 5 mL in 1 BOTTLE | SOLUTION | 5 | 4 | |
| 61919-795-25 | CIPROFLOXACIN | 25 mL in 1 BOTTLE | SOLUTION | 25 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-795-05 | ML - Milliliter | 61919-795 | b8556c57-00c8-447d-954c-a04f962049ec | 1 | 2019-10-07 |
| 61919-795-25 | ML - Milliliter | 61919-795 | 434d54c2-c678-45c8-8032-1f668021367a | 1 | 2019-11-12 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 309307 | ciprofloxacin HCl 0.3 % Ophthalmic Solution | PSN | 8e5e9dff-19e8-3098-e053-2a95a90aa96a | 4 |
| 309307 | ciprofloxacin 3 MG/ML Ophthalmic Solution | SCD | 8e5e9dff-19e8-3098-e053-2a95a90aa96a | 4 |
| 309307 | ciprofloxacin 0.3 % Ophthalmic Solution | SY | 8e5e9dff-19e8-3098-e053-2a95a90aa96a | 4 |
| 309307 | ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic Solution | SY | 8e5e9dff-19e8-3098-e053-2a95a90aa96a | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61919-795-05 | 61919079505 | 5 mL in 1 BOTTLE (61919-795-05) | 5 ml | 2019-07-23 | 0000-00-00 | No | No | Current |
| 61919-795-25 | 61919079525 | 25 mL in 1 BOTTLE (61919-795-25) | 25 ml | 2019-07-23 | 0000-00-00 | No | No | Current |