rifabutin
- Product NDC
- 68180-285
- 11-digit product format
- 681800285
- Labeler code
- 68180
- Product ID
- 68180-285_41b20170-81b4-4060-a85d-810249ba2d4a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rifabutin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA090033
- Marketing category
- ANDA
- Marketing start
- 2014-03-26
- Marketing end
- 0000-00-00
- Substance
- RIFABUTIN
- Active strength
- 150 mg/1
- Pharmacologic classes
- Rifamycin Antimycobacterial [EPC], Rifamycins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| RIFABUTIN | ACTIVE INGREDIENT | 1W306TDA6S | RIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| RIFABUTIN | ACTIVE MOIETY | 1W306TDA6S | RIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | RIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | RIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | RIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | RIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | RIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | RIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | RIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | RIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-285 | RIFABUTIN CAPSULE [LUPIN PHARMACEUTICALS, INC.] | 11 | Legacy NDC | 20250302_4be9cc3f-0016-4426-a700-574b45ce245b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68180-285-01 | 68180028501 | 100 CAPSULE in 1 BOTTLE (68180-285-01) | 100 capsule | 2014-03-26 | 0000-00-00 | No | No | Current |
| 68180-285-07 | 68180028507 | 60 CAPSULE in 1 BOTTLE (68180-285-07) | 60 capsule | 2014-03-26 | 0000-00-00 | No | No | Current |