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United States · US · US:85592-829_ef4e6e26-7b7d-4c48-8cc8-c101cc24d6f9
LACTULOSE
Orange BookUNIISPLATC A06AD11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCumberland Assured Products Inc.
CountryUS (United States)
ATC codeA06AD11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11855928293030 POUCH in 1 CARTON (85592-829-30) / 20 g in 1 POUCH (85592-829-01)
Annotations
UNII (FDA Substance ID)
9U7D5QH5AE
LACTULOSE
RxCUI 6218
Orange Book
A074712
AAAA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9U7D5QH5AE",
"rxcui": "6218",
"inchikey": "PFCRQPBOOFTZGQ-VZXVHDRGSA-N",
"display_name": "LACTULOSE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"3cf3ff7c-67e7-42a9-8ebb-bd6c53937dd7": {
"match": "brand_token",
"title": "LACTULOSE SOLUTION [CARDINAL HEALTH 107, LLC]",
"spl_version": "11",
"published_date": "2026-06-01"
}
},
"productid": "85592-829_ef4e6e26-7b7d-4c48-8cc8-c101cc24d6f9",
"productndc": "85592-829",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "074712",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "10GM/PACKET",
"product_no": "001",
"approval_date": "Dec 10, 1997"
},
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "20GM/PACKET",
"product_no": "002",
"approval_date": "Dec 10, 1997"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LACTULOSE",
"proprietary_name": "LACTULOSE",
"active_ingred_unit": "g/20g",
"application_number": "ANDA074712",
"marketing_category": "ANDA",
"nonproprietary_name": "lactulose",
"start_marketing_date": "20250901",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A06AD11.
- NLAlbert Heijn Laxeerdrank Lactulose 667 mg/ml, stroopHealthypharm B.V.
- GBBifiteral 10g oral powder sachetsImported (Germany)
- BEBifiteral 66.7 g/100 mlCooper Consumer Health
- IEBrillphalac 3.335 g/5 ml oral solutionBrillpharma (Ireland) Limited
- 🇺🇸ConstuloseActavis Pharma, Inc.
- PLDuphalacCooper Consumer Health B.V.
- 🇨🇭Duphalac
- PLDuphalacInPharm Sp. z o.o.
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