Sulfamethoxazole and Trimethoprim
- Product NDC
- 0527-5180
- 11-digit product format
- 005275180
- Labeler code
- 0527
- Product ID
- 0527-5180_3ba87fe1-d20e-431e-a4e1-54ba0c2ad8fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulfamethoxazole and Trimethoprim
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA077785
- Marketing category
- ANDA
- Marketing start
- 2007-01-24
- Marketing end
- 0000-00-00
- Substance
- SULFAMETHOXAZOLE; TRIMETHOPRIM
- Active strength
- 200 mg/5mL; mg/5mL
- Pharmacologic classes
- Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4ce811b5-329e-27f8-b5ff-66d52b435c00 | Product name | 3 | 20240108 |
| 8d30c4f0-0228-cea4-e3aa-f19064c47f27 | Product name | 3 | 20221128 |
| 6e20c430-5e8f-85da-1b03-f7dbc0c51fad | Product name | 3 | 20190926 |
| c1381fd7-868a-f499-ef90-8f6d3e3ee6b3 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0527-5180-70 | ML - Milliliter | 0527-5180 | e6492812-2f0d-46cc-8025-db89908ff2fa | 1 | 2020-06-05 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313134 | sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral Suspension | PSN | e2a018ad-31aa-47d2-b96b-e7a1deee0976 | 1 |
| 313134 | sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral Suspension | SCD | e2a018ad-31aa-47d2-b96b-e7a1deee0976 | 1 |
| 313134 | SMX 40 MG/ML / TMP 8 MG/ML Oral Suspension | SY | e2a018ad-31aa-47d2-b96b-e7a1deee0976 | 1 |
| 313134 | sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral Suspension | SY | e2a018ad-31aa-47d2-b96b-e7a1deee0976 | 1 |
| 313134 | sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral Suspension | SY | e2a018ad-31aa-47d2-b96b-e7a1deee0976 | 1 |
| 313134 | sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral Suspension | SY | e2a018ad-31aa-47d2-b96b-e7a1deee0976 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0527-5180-70 | 00527518070 | 473 mL in 1 BOTTLE (0527-5180-70) | 473 ml | 2007-01-24 | 0000-00-00 | No | No | Current |