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United States · US · US:64980-592_ae4387e8-ba31-4378-9e67-98effdcc998f
Lactulose Solution
Orange BookUNIISPLATC A06AD11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeA06AD11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc116498059212118 mL in 1 BOTTLE (64980-592-12)
- ndc116498059224236 mL in 1 BOTTLE (64980-592-24)
- ndc116498059248473 mL in 1 BOTTLE (64980-592-48)
- ndc116498059295946 mL in 1 BOTTLE (64980-592-95)
Annotations
UNII (FDA Substance ID)
9U7D5QH5AE
LACTULOSE
RxCUI 6218
Orange Book
A076645
AA
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; RECTAL",
"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": "64980-592_ae4387e8-ba31-4378-9e67-98effdcc998f",
"productndc": "64980-592",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "076645",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10GM/15ML",
"product_no": "001",
"approval_date": "Jul 28, 2003"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LACTULOSE",
"proprietary_name": "Lactulose Solution",
"active_ingred_unit": "g/15mL",
"application_number": "ANDA076645",
"marketing_category": "ANDA",
"nonproprietary_name": "Lactulose Solution USP, 10 g/15 mL",
"start_marketing_date": "20211014",
"active_numerator_strength": "10"
}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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