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United States · US · US:0121-1746_b73c2ddc-a690-46e1-aa89-40fa890c9ab4
LACTULOSE
Orange BookUNIISPLATC A06AD11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPAI Holdings, LLC dba PAI Pharma
CountryUS (United States)
ATC codeA06AD11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11012117460010 TRAY in 1 CASE (0121-1746-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0121-1746-30)
- ndc1101211746066 CARTON in 1 CASE (0121-1746-06) / 16 CUP, UNIT-DOSE in 1 CARTON / 30 mL in 1 CUP, UNIT-DOSE (0121-1746-30)
- ndc1101211746404 TRAY in 1 CASE (0121-1746-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE (0121-1746-30)
Annotations
UNII (FDA Substance ID)
9U7D5QH5AE
LACTULOSE
RxCUI 6218
Orange Book
A074623
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": "0121-1746_b73c2ddc-a690-46e1-aa89-40fa890c9ab4",
"productndc": "0121-1746",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "074623",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "10GM/15ML",
"product_no": "001",
"approval_date": "Jul 30, 1996"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LACTULOSE",
"proprietary_name": "LACTULOSE",
"active_ingred_unit": "g/30mL",
"application_number": "ANDA074623",
"marketing_category": "ANDA",
"nonproprietary_name": "LACTULOSE",
"start_marketing_date": "20191203",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code A06AD11.
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- GBBifiteral 10g oral powder sachetsImported (Germany)
- BEBifiteral 66.7 g/100 mlCooper Consumer Health
- IEBrillphalac 3.335 g/5 ml oral solutionBrillpharma (Ireland) Limited
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- PLDuphalacCooper Consumer Health B.V.
- 🇨🇭Duphalac
- PLDuphalacInPharm Sp. z o.o.
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