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United States · US · US:83745-405_b0b2ff56-185f-4e6e-9519-14af29f765e8
Lactulose
Orange BookUNIISPLATC A06AD11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAPOZEAL PHARMACEUTICALS INC
CountryUS (United States)
ATC codeA06AD11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc118374540508237 mL in 1 BOTTLE (83745-405-08)
- ndc118374540516473 mL in 1 BOTTLE (83745-405-16)
- ndc118374540532946 mL in 1 BOTTLE (83745-405-32)
Annotations
UNII (FDA Substance ID)
9U7D5QH5AE
LACTULOSE
RxCUI 6218
Orange Book
A207786
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",
"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": "83745-405_b0b2ff56-185f-4e6e-9519-14af29f765e8",
"productndc": "83745-405",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "207786",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10GM/15ML",
"product_no": "001",
"approval_date": "Jun 11, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LACTULOSE",
"proprietary_name": "Lactulose",
"active_ingred_unit": "g/15mL",
"application_number": "ANDA207786",
"marketing_category": "ANDA",
"nonproprietary_name": "Lactulose",
"start_marketing_date": "20241220",
"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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