Sulfadiazine
- Product NDC
- 0185-0757
- 11-digit product format
- 001850757
- Labeler code
- 0185
- Product ID
- 0185-0757_4435aed7-872c-4439-b5d7-4abd212f4a1e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulfadiazine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Eon Labs, Inc.
- Application
- ANDA040091
- Marketing category
- ANDA
- Marketing start
- 1994-07-29
- Marketing end
- 2024-05-31
- Substance
- SULFADIAZINE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Sulfonamide Antibacterial [EPC],Sulfonamides [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0185-0757-01 | 2020-12-04 | C162847 | 48780-1 | 9d75b9d0-bce6-f424-e053-dadaa90a57ce | 10549cba-9c15-4d2e-a68c-5afbc178591d |
| 0185-0757-10 | 2020-12-04 | C162847 | 48780-1 | 9d75b9d0-bce6-f424-e053-dadaa90a57ce | 10549cba-9c15-4d2e-a68c-5afbc178591d |
| 0185-0757-30 | 2020-12-04 | C162847 | 48780-1 | 9d75b9d0-bce6-f424-e053-dadaa90a57ce | 10549cba-9c15-4d2e-a68c-5afbc178591d |
| 0185-0757-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bce6-f424-e053-dadaa90a57ce | 10549cba-9c15-4d2e-a68c-5afbc178591d |
| 0185-0757-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bce6-f424-e053-dadaa90a57ce | 10549cba-9c15-4d2e-a68c-5afbc178591d |
| 0185-0757-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-bce6-f424-e053-dadaa90a57ce | 10549cba-9c15-4d2e-a68c-5afbc178591d |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0185-0757-01 | EA - Each | 0185-0757 | 8746297f-9e86-47ea-9812-4c936beaf62c | 1 | 2012-07-24 |
| 0185-0757-10 | EA - Each | 0185-0757 | 7abd3d9c-1c2f-4b05-9535-575c1c13720e | 1 | 2012-07-24 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0185-0757-01 | 00185075701 | 100 TABLET in 1 BOTTLE (0185-0757-01) | 100 tablet | 1994-07-29 | 2024-05-31 | No | No | Current |