DIMETHYL FUMARATE
- Product NDC
- 69097-323
- 11-digit product format
- 690970323
- Labeler code
- 69097
- Product ID
- 69097-323_d64e8be8-de52-40c2-8730-bef67c6b0914
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DIMETHYL FUMARATE
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA210305
- Marketing category
- ANDA
- Marketing start
- 2020-09-24
- Substance
- DIMETHYL FUMARATE
- Active strength
- 240 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DIMETHYL FUMARATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIMETHYL FUMARATE | 240 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FO2303MNI2 |
| Rxcui | 1373483, 1373491, 1373497 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69097-323-03 | DIMETHYL FUMARATE | 60 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 60 | | 10 |
| 69097-323-03 | DIMETHYL FUMARATE | 1 in 1 CARTON | CAPSULE, DELAYED RELEASE | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-323 | DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE DIMETHYL FUMARATE KIT [CIPLA USA INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240415_6c42107a-2a42-4263-97b6-ae0d7675c92a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69097-323-03 | 69097032303 | 1 BOTTLE, PLASTIC in 1 CARTON (69097-323-03) / 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC | 2020-09-24 | 0000-00-00 | No | No | Current |