Rifabutin
- Product NDC
- 10135-738
- 11-digit product format
- 101350738
- Labeler code
- 10135
- Product ID
- 10135-738_43e1cc33-400c-6f7d-e063-6394a90ab38d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rifabutin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals, Inc.
- Application
- ANDA215041
- Marketing category
- ANDA
- Marketing start
- 2022-05-01
- Substance
- RIFABUTIN
- Active strength
- 150 mg/1
- Pharmacologic classes
- Rifamycin Antimycobacterial [EPC], Rifamycins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rifabutin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| RIFABUTIN | 150 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1W306TDA6S |
| Rxcui | 198200 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-738-01 | Rifabutin | 100 in 1 BOTTLE | CAPSULE | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-738 | RIFABUTIN CAPSULE [MARLEX PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20241018_df7d4103-42e4-4e4f-e053-2a95a90a8ce8.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 |
|---|
| 10135-738-01 | 10135073801 | 100 CAPSULE in 1 BOTTLE (10135-738-01) | 100 capsule | 2022-05-01 | 0000-00-00 | No | No | Current |