NDC 10631-005

Absorica LD

Isotretinoin

Absorica LD is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Isotretinoin.

Product ID10631-005_2624e8da-e473-4136-b6c6-a59b6cc14d01
NDC10631-005
Product TypeHuman Prescription Drug
Proprietary NameAbsorica LD
Generic NameIsotretinoin
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2019-11-20
Marketing CategoryNDA / NDA
Application NumberNDA211913
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameISOTRETINOIN
Active Ingredient Strength24 mg/1
Pharm ClassesRetinoid [EPC],Retinoids [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 10631-005-31

3 BLISTER PACK in 1 BOX (10631-005-31) > 10 CAPSULE in 1 BLISTER PACK
Marketing Start Date2019-11-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10631-005-31 [10631000531]

Absorica LD CAPSULE
Marketing CategoryNDA
Application NumberNDA211913
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-11-20

Drug Details

Active Ingredients

IngredientStrength
ISOTRETINOIN24 mg/1

Pharmacological Class

  • Retinoid [EPC]
  • Retinoids [CS]

NDC Crossover Matching brand name "Absorica LD" or generic name "Isotretinoin"

NDCBrand NameGeneric Name
10631-005Absorica LDAbsorica LD
10631-006Absorica LDAbsorica LD
10631-002Absorica LDAbsorica LD
10631-003Absorica LDAbsorica LD
10631-007Absorica LDAbsorica LD
10631-004Absorica LDAbsorica LD
0378-6611Amnesteemisotretinoin
0378-6612Amnesteemisotretinoin
0378-6614Amnesteemisotretinoin
0555-1054ClaravisIsotretinoin
0555-1055ClaravisIsotretinoin
0555-1056ClaravisIsotretinoin
0555-1057ClaravisIsotretinoin
0245-0570IsotretinoinIsotretinoin
0245-0571IsotretinoinIsotretinoin
0245-0573IsotretinoinIsotretinoin
0245-0575IsotretinoinIsotretinoin

Trademark Results [Absorica LD]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ABSORICA LD
ABSORICA LD
88802710 not registered Live/Pending
Sun Pharmaceutical Industries, Inc.
2020-02-19
ABSORICA LD
ABSORICA LD
88173525 not registered Live/Pending
Sun Pharmaceutical Industries, Inc.
2018-10-29

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