NDC 10631-116 – Absorica
Isotretinoin 20 mg/1 · Capsule · Oral
Product NDC10631-116
Product details
- Brand name
- Absorica
- Generic name
- Isotretinoin
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Dosage form
- Capsule
- Route
- Oral
- Marketing category
- NDA · NDA021951
- Marketed since
- June 8, 2012
- Listing expires
- December 31, 2027
- Pharmacologic class
- Retinoid
Active ingredients
- Isotretinoin 20 mg/1
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 10631-116-31 | 3 BLISTER PACK in 1 BOX (10631-116-31) / 10 CAPSULE in 1 BLISTER PACK (10631-116-69) | Jun 8, 2012 |
Recalls mentioning this NDC
- D-1207-2019 Dec 26, 2018 · Class III
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring. - D-1288-2015 Aug 12, 2015 · Class II
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Other Absorica products
- 10631-115 Isotretinoin 10 mg/1 · Capsule · Sun Pharmaceutical Industries, Inc.
- 10631-117 Isotretinoin 30 mg/1 · Capsule · Sun Pharmaceutical Industries, Inc.
- 10631-118 Isotretinoin 40 mg/1 · Capsule · Sun Pharmaceutical Industries, Inc.
- 10631-133 Isotretinoin 25 mg/1 · Capsule · Sun Pharmaceutical Industries, Inc.
- 10631-134 Isotretinoin 35 mg/1 · Capsule · Sun Pharmaceutical Industries, Inc.