FDA.reportPublic FDA data

Absorica LD

Product NDC
10631-004
11-digit product format
106310004
Labeler code
10631
Product ID
10631-004_3676a3d3-04f6-4b0d-ace2-8a39c20185c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isotretinoin
Dosage form
CAPSULE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA211913
Marketing category
NDA
Marketing start
2019-11-20
Marketing end
0000-00-00
Substance
ISOTRETINOIN
Active strength
20 mg/1
Pharmacologic classes
Retinoid [EPC],Retinoids [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8300c0f6-79a4-735b-88ec-d781bfffdb10Product name520260305
644afe93-ba9b-4043-8e40-a9fe9af2d5d7Product name220250616
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
e5fedfa5-6b96-4769-872b-95d1e7f3a85aProduct name120200415
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10631-004-31Absorica LD10 in 1 BLISTER PACKCAPSULE1018
10631-004-31Absorica LD3 in 1 BOXCAPSULE318

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10631-004ABSORICA (ISOTRETINOIN) CAPSULE ABSORICA LD (ISOTRETINOIN) CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]18Legacy NDC, 2 package rows20231003_3ef0cff8-19c1-4441-b780-fca6c7ee1615.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1299203Absorica 10 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
1300006Absorica 20 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
1547563Absorica 25 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
1300014Absorica 30 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
1547567Absorica 35 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
1300016Absorica 40 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262713Absorica LD 16 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262715Absorica LD 20 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262719Absorica LD 24 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262723Absorica LD 28 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262727Absorica LD 32 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262731Absorica LD 8 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
197843ISOtretinoin 10 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
197844ISOtretinoin 20 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
1547561ISOtretinoin 25 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
403930ISOtretinoin 30 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
1547565ISOtretinoin 35 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
197845ISOtretinoin 40 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262711ISOtretinoin micronized 16 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262714ISOtretinoin micronized 20 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262717ISOtretinoin micronized 24 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262721ISOtretinoin micronized 28 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262725ISOtretinoin micronized 32 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262729ISOtretinoin micronized 8 MG Oral CapsulePSN3ef0cff8-19c1-4441-b780-fca6c7ee161518
1299203isotretinoin 10 MG Oral Capsule [Absorica]SBD3ef0cff8-19c1-4441-b780-fca6c7ee161518
1300006isotretinoin 20 MG Oral Capsule [Absorica]SBD3ef0cff8-19c1-4441-b780-fca6c7ee161518
1547563isotretinoin 25 MG Oral Capsule [Absorica]SBD3ef0cff8-19c1-4441-b780-fca6c7ee161518
1300014isotretinoin 30 MG Oral Capsule [Absorica]SBD3ef0cff8-19c1-4441-b780-fca6c7ee161518
1547567isotretinoin 35 MG Oral Capsule [Absorica]SBD3ef0cff8-19c1-4441-b780-fca6c7ee161518
1300016isotretinoin 40 MG Oral Capsule [Absorica]SBD3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262713Micronized isotretinoin 16 MG Oral Capsule [Absorica]SBD3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262715Micronized isotretinoin 20 MG Oral Capsule [Absorica]SBD3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262719Micronized isotretinoin 24 MG Oral Capsule [Absorica]SBD3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262723Micronized isotretinoin 28 MG Oral Capsule [Absorica]SBD3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262727Micronized isotretinoin 32 MG Oral Capsule [Absorica]SBD3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262731Micronized isotretinoin 8 MG Oral Capsule [Absorica]SBD3ef0cff8-19c1-4441-b780-fca6c7ee161518
197843isotretinoin 10 MG Oral CapsuleSCD3ef0cff8-19c1-4441-b780-fca6c7ee161518
197844isotretinoin 20 MG Oral CapsuleSCD3ef0cff8-19c1-4441-b780-fca6c7ee161518
1547561isotretinoin 25 MG Oral CapsuleSCD3ef0cff8-19c1-4441-b780-fca6c7ee161518
403930isotretinoin 30 MG Oral CapsuleSCD3ef0cff8-19c1-4441-b780-fca6c7ee161518
1547565isotretinoin 35 MG Oral CapsuleSCD3ef0cff8-19c1-4441-b780-fca6c7ee161518
197845isotretinoin 40 MG Oral CapsuleSCD3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262711Micronized isotretinoin 16 MG Oral CapsuleSCD3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262714Micronized isotretinoin 20 MG Oral CapsuleSCD3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262717Micronized isotretinoin 24 MG Oral CapsuleSCD3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262721Micronized isotretinoin 28 MG Oral CapsuleSCD3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262725Micronized isotretinoin 32 MG Oral CapsuleSCD3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262729Micronized isotretinoin 8 MG Oral CapsuleSCD3ef0cff8-19c1-4441-b780-fca6c7ee161518
1299203Absorica 10 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
1300006Absorica 20 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
1547563Absorica 25 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
1300014Absorica 30 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
1547567Absorica 35 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
1300016Absorica 40 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262713Absorica LD 16 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262715Absorica LD 20 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262719Absorica LD 24 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262723Absorica LD 28 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262727Absorica LD 32 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262731Absorica LD 8 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262711isotretinoin micronized 16 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262714isotretinoin micronized 20 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262717isotretinoin micronized 24 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262721isotretinoin micronized 28 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262725isotretinoin micronized 32 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262729isotretinoin micronized 8 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262713Micronized Absorica 16 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262715Micronized Absorica 20 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262719Micronized Absorica 24 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262723Micronized Absorica 28 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262727Micronized Absorica 32 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518
2262731Micronized Absorica 8 MG Oral CapsuleSY3ef0cff8-19c1-4441-b780-fca6c7ee161518

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10631-004-311063100043110 in 1 BLISTER PACKHistorical