Myorisan
- Product NDC
- 61748-301
- 11-digit product format
- 617480301
- Labeler code
- 61748
- Product ID
- 61748-301_3e34f054-8b03-4d79-821c-593120c49ea2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- isotretinoin
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Akorn Operating Company LLC
- Application
- ANDA076485
- Marketing category
- ANDA
- Marketing start
- 2012-05-01
- Marketing end
- 0000-00-00
- Substance
- ISOTRETINOIN
- Active strength
- 10 mg/1
- Pharmacologic classes
- Retinoid [EPC], Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 61748-301-01 | 2024-01-30 | C162847 | 48780-1 | 1030e364-fd70-111a-e063-dadaa90a10e2 | Myorisan ® (isotretinoin capsules, USP) 10 mg, 20 mg, 30 mg, 40 mg |
| 61748-301-11 | 2024-01-30 | C162847 | 48780-1 | 1030e364-fd70-111a-e063-dadaa90a10e2 | Myorisan ® (isotretinoin capsules, USP) 10 mg, 20 mg, 30 mg, 40 mg |
| 61748-301-13 | 2024-01-30 | C162847 | 48780-1 | 1030e364-fd70-111a-e063-dadaa90a10e2 | Myorisan ® (isotretinoin capsules, USP) 10 mg, 20 mg, 30 mg, 40 mg |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61748-301-01 | Myorisan | 5000 in 1 BAG | CAPSULE, LIQUID FILLED | 5000 | | 14 |
| 61748-301-11 | Myorisan | 10 in 1 CARTON | CAPSULE, LIQUID FILLED | 10 | | 14 |
| 61748-301-11 | Myorisan | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | | 14 |
| 61748-301-13 | Myorisan | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | | 14 |
| 61748-301-13 | Myorisan | 3 in 1 CARTON | CAPSULE, LIQUID FILLED | 3 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ISOTRETINOIN | ACTIVE INGREDIENT | EH28UP18IF | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| ISOTRETINOIN | ACTIVE MOIETY | EH28UP18IF | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| .ALPHA.-TOCOPHEROL, DL- | INACTIVE INGREDIENT | 7QWA1RIO01 | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| HYDROGENATED SOYBEAN OIL | INACTIVE INGREDIENT | A2M91M918C | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| SOYBEAN OIL | INACTIVE INGREDIENT | 241ATL177A | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [VERSAPHARM INCORPORATED] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61748-301 | MYORISAN (ISOTRETINOIN) CAPSULE, LIQUID FILLED [AKORN OPERATING COMPANY LLC] | 14 | Legacy NDC, 5 package rows | 20221220_51ff6346-9256-4c01-9f52-417d13f2df05.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 |
|---|
| 61748-301-01 | 61748030101 | 5000 CAPSULE, LIQUID FILLED in 1 BAG (61748-301-01) | | 2012-05-01 | 0000-00-00 | No | No | Current |
| 61748-301-11 | 61748030111 | 10 BLISTER PACK in 1 CARTON (61748-301-11) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 10 blister pack | 2012-05-01 | 0000-00-00 | No | No | Current |
| 61748-301-13 | 61748030113 | 3 BLISTER PACK in 1 CARTON (61748-301-13) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 3 blister pack | 2012-05-01 | 0000-00-00 | No | No | Current |