Mycophenolic Acid
- Product NDC
- 68084-918
- 11-digit product format
- 680840918
- Labeler code
- 68084
- Product ID
- 68084-918_27ea2d9a-52b6-818e-e063-6394a90a52c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mycophenolic Acid
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA091558
- Marketing category
- ANDA
- Marketing start
- 2015-04-02
- Substance
- MYCOPHENOLATE SODIUM
- Active strength
- 360 mg/1
- Pharmacologic classes
- Antimetabolite Immunosuppressant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mycophenolic Acid
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MYCOPHENOLATE SODIUM | 360 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WX877SQI1G |
| Rxcui | 485020, 485023 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-918-25 | Mycophenolic Acid | 30 in 1 BOX, UNIT-DOSE | TABLET, DELAYED RELEASE | 30 | | 9 |
| 68084-918-95 | Mycophenolic Acid | 1 in 1 BLISTER PACK | TABLET, DELAYED RELEASE | 1 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MYCOPHENOLATE SODIUM | ACTIVE INGREDIENT | WX877SQI1G | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 1 | |
| mycophenolic acid | ACTIVE MOIETY | HU9DX48N0T | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 1 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 1 | |
| METHYLCELLULOSE (400 MPA.S) | INACTIVE INGREDIENT | O0GN6F9B2Y | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 1 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-918 | MYCOPHENOLIC ACID TABLET, DELAYED RELEASE [AMERICAN HEALTH PACKAGING] | 9 | Current NDC, Legacy NDC, 2 package rows | 20241129_26b31126-4262-4a15-8a16-234c86763176.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 |
|---|
| 68084-918-25 | 68084091825 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-918-25) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68084-918-95) | 30 blister pack | 2015-04-02 | 0000-00-00 | No | No | Current |
| 68084-918-95 | 68084091895 | 1 in 1 BLISTER PACK | | | | | | Historical |