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United States · US · US:62135-892_1d600b06-58c7-b83e-e063-6294a90a86f9
Generlac
Orange BookUNIISPLATC A06AD11
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC codeA06AD11
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116213589247473 mL in 1 BOTTLE (62135-892-47)
- ndc116213589294946 mL in 1 BOTTLE (62135-892-94)
Annotations
UNII (FDA Substance ID)
9U7D5QH5AE
LACTULOSE
RxCUI 6218
Orange Book
A074603
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": {
"35207edd-a5fe-4369-a079-7a8b0d2f2e91": {
"match": "brand_token",
"title": "GENERLAC (LACTULOSE) SOLUTION [CHARTWELL RX, LLC]",
"spl_version": "1",
"published_date": "2024-07-18"
}
},
"productid": "62135-892_1d600b06-58c7-b83e-e063-6294a90a86f9",
"productndc": "62135-892",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "074603",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "10GM/15ML",
"product_no": "001",
"approval_date": "Oct 31, 1996"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LACTULOSE",
"proprietary_name": "Generlac",
"active_ingred_unit": "g/15mL",
"application_number": "ANDA074603",
"marketing_category": "ANDA",
"nonproprietary_name": "Lactulose",
"start_marketing_date": "19961031",
"active_numerator_strength": "10"
}Related drugs
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- IEBrillphalac 3.335 g/5 ml oral solutionBrillpharma (Ireland) Limited
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- PLDuphalacInPharm Sp. z o.o.
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