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United States · US · US:70954-417_0635706e-180e-435e-92cf-c85e0ca4f7e0
L-Glutamine
Orange BookUNIISPLATC A16AA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA16AA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11709544172060 PACKET in 1 CARTON (70954-417-20) / 1 POWDER, FOR SOLUTION in 1 PACKET (70954-417-10)
Annotations
UNII (FDA Substance ID)
0RH81L854J
GLUTAMINE
RxCUI 4885
Orange Book
A215647
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "0RH81L854J",
"rxcui": "4885",
"inchikey": "ZDXPYRJPNDTMRX-VKHMYHEASA-N",
"display_name": "GLUTAMINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"3f324755-159b-40ee-a9f4-e6800558acf3": {
"match": "brand_token",
"title": "L-GLUTAMINE POWDER, FOR SOLUTION [RENOVA PHARMACEUTICALS LLC]",
"spl_version": "2",
"published_date": "2026-05-28"
}
},
"productid": "70954-417_0635706e-180e-435e-92cf-c85e0ca4f7e0",
"productndc": "70954-417",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "215647",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "5GM/PACKET",
"product_no": "001",
"approval_date": "Jul 8, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "GLUTAMINE",
"proprietary_name": "L-Glutamine",
"active_ingred_unit": "g/1",
"application_number": "ANDA215647",
"marketing_category": "ANDA",
"nonproprietary_name": "L-Glutamine",
"start_marketing_date": "20240711",
"active_numerator_strength": "5"
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