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United States · US · US:68083-351_71422270-6a76-40e5-bd89-643b8b2fafd5
Ertapenem
Orange BookUNIISPLATC J01DH03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeJ01DH03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11680833511010 VIAL, SINGLE-DOSE in 1 CARTON (68083-351-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68083-351-01)
Annotations
UNII (FDA Substance ID)
2T90KE67L0
ERTAPENEM SODIUM
RxCUI 353107
Orange Book
A212040
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2T90KE67L0",
"rxcui": "353107",
"inchikey": "ZXNAQFZBWUNWJM-HRXMHBOMSA-M",
"display_name": "ERTAPENEM SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRAVENOUS",
"spl_meta": {
"657855f2-7c92-4aa8-9c3d-51d08e56a09a": {
"match": "brand_token",
"title": "ERTAPENEM (ERTAPENEM SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.]",
"spl_version": "13",
"published_date": "2026-04-09"
}
},
"productid": "68083-351_71422270-6a76-40e5-bd89-643b8b2fafd5",
"productndc": "68083-351",
"dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"orange_book": {
"appl_no": "212040",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 1GM BASE/VIAL",
"product_no": "001",
"approval_date": "Mar 26, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ERTAPENEM SODIUM",
"proprietary_name": "Ertapenem",
"active_ingred_unit": "g/1",
"application_number": "ANDA212040",
"marketing_category": "ANDA",
"nonproprietary_name": "Ertapenem Sodium",
"start_marketing_date": "20210326",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code J01DH03.
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