Rifabutin
- Product NDC
- 70518-4254
- 11-digit product format
- 705184254
- Labeler code
- 70518
- Product ID
- 70518-4254_40089d1e-2431-3042-e063-6394a90afb4a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rifabutin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA050689
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2025-01-13
- 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 |
|---|
| 70518-4254-0 | Rifabutin | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4254 | RIFABUTIN CAPSULE [REMEDYREPACK INC.] | 1 | Current NDC, 1 package rows | 20250114_25a60937-cbbe-4a50-994f-2ce15203f589.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4254-0 | 70518425400 | 60 CAPSULE in 1 BOTTLE, PLASTIC (70518-4254-0) | 60 capsule | 2025-01-13 | No | No | Current |