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United States · US · US:43386-680_21e7776e-65d0-45fb-a1b2-13f49055ad64
PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Orange BookUNIISPLATC A06AH
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLupin Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeA06AH
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc114338668001100 TABLET in 1 BOTTLE (43386-680-01)
Annotations
UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
A075735
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "F850569PQR",
"rxcui": "203192",
"inchikey": "RGPDIGOSVORSAK-STHHAXOLSA-N",
"display_name": "NALOXONE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"a28450a0-ac93-4235-b9a6-58cdf24773cb": {
"match": "brand_token",
"title": "PENTAZOCINE AND NALOXONE (PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.]",
"spl_version": "28",
"published_date": "2026-01-16"
}
},
"productid": "43386-680_21e7776e-65d0-45fb-a1b2-13f49055ad64",
"productndc": "43386-680",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "075735",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.5MG BASE;EQ 50MG BASE",
"product_no": "001",
"approval_date": "Jul 11, 2001"
}
],
"appl_type": "A"
},
"dea_schedule": "CIV",
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE",
"proprietary_name": "PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA075735",
"marketing_category": "ANDA",
"nonproprietary_name": "pentazocine hydrochloride and naloxone hydrochloride",
"start_marketing_date": "20110511",
"active_numerator_strength": ".5; 50"
}Related drugs
Other records sharing ATC code A06AH.
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