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United States · US · US:0049-0530_0fe9ce5c-e7dc-4526-ab48-6f910e721efd
Pfizerpen
In shortageOrange BookUNIISPLATC J01CE01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRoerig
CountryUS (United States)
ATC codeJ01CE01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1100490530281 VIAL in 1 CARTON (0049-0530-28) / 1 POWDER, FOR SOLUTION in 1 VIAL
Annotations
UNII (FDA Substance ID)
VL775ZTH4C
PENICILLIN G POTASSIUM
RxCUI 203133
Orange Book
A060657
APAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Penicillin G Benzathine Injection
Raw payload (JSON)
{
"unii": {
"unii": "VL775ZTH4C",
"rxcui": "203133",
"inchikey": "IYNDLOXRXUOGIU-LQDWTQKMSA-M",
"display_name": "PENICILLIN G POTASSIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"efef4846-9497-41af-8dd6-518f86eca7f2": {
"match": "brand_token",
"title": "PFIZERPEN (PENICILLIN G POTASSIUM) POWDER, FOR SOLUTION [ROERIG]",
"spl_version": "21",
"published_date": "2025-12-17"
}
},
"productid": "0049-0530_0fe9ce5c-e7dc-4526-ab48-6f910e721efd",
"productndc": "0049-0530",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "060657",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "1,000,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "5,000,000 UNITS/VIAL",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "20,000,000 UNITS/VIAL",
"product_no": "003",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PENICILLIN G POTASSIUM",
"shortage_reason": "Penicillin G Benzathine Injection",
"shortage_status": "current",
"proprietary_name": "Pfizerpen",
"active_ingred_unit": "[iU]/1",
"application_number": "ANDA060657",
"marketing_category": "ANDA",
"nonproprietary_name": "penicillin G potassium",
"start_marketing_date": "20100601",
"active_numerator_strength": "20000000"
}Related drugs
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