Sulfamethox-TMP DS
- Product NDC
- 54348-625
- 11-digit product format
- 543480625
- Labeler code
- 54348
- Product ID
- 54348-625_ea935f93-6c2d-2e8a-e053-2995a90a2ce0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SULFAMETHOXAZOLE, TRIMETHOPRIM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PharmPak, Inc.
- Application
- ANDA076899
- Marketing category
- ANDA
- Marketing start
- 2019-07-11
- Substance
- SULFAMETHOXAZOLE; TRIMETHOPRIM
- Active strength
- 800; 160 mg/1; mg/1
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sulfamethox-TMP DS
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SULFAMETHOXAZOLE | 800 mg/1 |
| TRIMETHOPRIM | 160 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JE42381TNV, AN164J8Y0X |
| Rxcui | 198335 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54348-625 | SULFAMETHOX-TMP DS (SULFAMETHOXAZOLE, TRIMETHOPRIM) TABLET [PHARMPAK, INC.] | 2 | Current NDC, Legacy NDC, 8 package rows | 20221011_ede74118-32c5-4f52-9823-509538e674c8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54348-625-06 | 54348062506 | 1 BOTTLE in 1 BOX (54348-625-06) / 6 TABLET in 1 BOTTLE | 1 bottle | 2019-07-11 | 0000-00-00 | No | No | Current |
| 54348-625-10 | 54348062510 | 1 BOTTLE in 1 BOX (54348-625-10) / 10 TABLET in 1 BOTTLE | 1 bottle | 2019-07-11 | 0000-00-00 | No | No | Current |
| 54348-625-14 | 54348062514 | 1 BOTTLE in 1 BOX (54348-625-14) / 14 TABLET in 1 BOTTLE | 1 bottle | 2019-07-11 | 0000-00-00 | No | No | Current |
| 54348-625-20 | 54348062520 | 1 BOTTLE in 1 BOX (54348-625-20) / 20 TABLET in 1 BOTTLE | 1 bottle | 2019-07-11 | 0000-00-00 | No | No | Current |