ciprofloxacin
- Product NDC
- 50436-0412
- 11-digit product format
- 504360412
- Labeler code
- 50436
- Product ID
- 50436-0412_cad7a5ce-4dc3-42a9-b189-fd9201205c92
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ciprofloxacin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA076639
- Marketing category
- ANDA
- Marketing start
- 2004-09-10
- Marketing end
- 0000-00-00
- Substance
- CIPROFLOXACIN HYDROCHLORIDE
- Active strength
- 500 mg/1
- 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 |
| 90aab9f8-63f3-478d-8db8-951525a18ab1 | Product name | 1 | 20180814 |
| 200e1d3d-46da-4371-beed-747da3cb3ff8 | Product name | 1 | 20180702 |
| 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 |
| de5ea793-ffd9-0308-b0ca-00d9967be4ee | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50436-0412-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-374d-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use ciprofloxacin safely and effectively. See full prescribing information for Ciprofloxacin. ciprofloxacin (hydrochloride) tablets for Oral Use Initial U.S. Approval: 1987 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-0412-1 | ciprofloxacin | 6 in 1 BOTTLE | TABLET | 6 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-0412 | CIPROFLOXACIN TABLET CIPROFLOXACIN TABLET [UNIT DOSE SERVICES] | 5 | Legacy NDC, 1 package rows | 20180110_a6181900-4a14-426c-80e9-c73f8a820514.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197511 | ciprofloxacin 250 MG Oral Tablet | PSN | a6181900-4a14-426c-80e9-c73f8a820514 | 5 |
| 309309 | ciprofloxacin 500 MG Oral Tablet | PSN | a6181900-4a14-426c-80e9-c73f8a820514 | 5 |
| 197511 | ciprofloxacin 250 MG Oral Tablet | SCD | a6181900-4a14-426c-80e9-c73f8a820514 | 5 |
| 309309 | ciprofloxacin 500 MG Oral Tablet | SCD | a6181900-4a14-426c-80e9-c73f8a820514 | 5 |
| 309309 | ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral Tablet | SY | a6181900-4a14-426c-80e9-c73f8a820514 | 5 |
| 197511 | ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral Tablet | SY | a6181900-4a14-426c-80e9-c73f8a820514 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-0412-1 | 50436041201 | 6 in 1 BOTTLE | Historical |