Naltrexone Hydrochloride
- Product NDC
- 51224-206
- 11-digit product format
- 512240206
- Labeler code
- 51224
- Product ID
- 51224-206_75a00517-674b-4e87-b37b-598486aedf03
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naltrexone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- TAGI Pharma Inc.
- Application
- ANDA075274
- Marketing category
- ANDA
- Marketing start
- 2013-09-23
- Marketing end
- 2027-11-30
- Substance
- NALTREXONE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naltrexone Hydrochloride
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NALTREXONE HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | Z6375YW9SF |
| Rxcui | 1483744 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51224-206-30 | Naltrexone Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
| 51224-206-50 | Naltrexone Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| naltrexone Hydrochloride | ACTIVE INGREDIENT | Z6375YW9SF | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] | 1 | |
| Naltrexone Hydrochloride | ACTIVE INGREDIENT | Z6375YW9SF | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.] | 1 | |
| Naltrexone Hydrochloride | ACTIVE INGREDIENT | Z6375YW9SF | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| Naltrexone | ACTIVE MOIETY | 5S6W795CQM | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.] | 1 | |
| naltrexone | ACTIVE MOIETY | 5S6W795CQM | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] | 1 | |
| Naltrexone | ACTIVE MOIETY | 5S6W795CQM | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| anhydrous lactose | INACTIVE INGREDIENT | 3SY5LH9PMK | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| anhydrous lactose | INACTIVE INGREDIENT | 3SY5LH9PMK | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.] | 1 | |
| anhydrous lactose | INACTIVE INGREDIENT | 3SY5LH9PMK | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.] | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.] | 1 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] | 1 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.] | 1 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] | 1 | |
| hydroxypropyl cellulose (type h) | INACTIVE INGREDIENT | RFW2ET671P | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.] | 1 | |
| hydroxypropyl cellulose (type h) | INACTIVE INGREDIENT | RFW2ET671P | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] | 1 | |
| hydroxypropyl cellulose (type h) | INACTIVE INGREDIENT | RFW2ET671P | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.] | 1 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] | 1 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.] | 1 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] | 1 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.] | 1 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.] | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51224-206 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [TAGI PHARMA INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20190619_60276f5c-657a-4b60-bcd0-44234903d7e0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51224-206-30 | 51224020630 | 30 TABLET, FILM COATED in 1 BOTTLE (51224-206-30) | 2013-09-23 | 2027-11-30 | No | No | Current |
| 51224-206-50 | 51224020650 | 100 TABLET, FILM COATED in 1 BOTTLE (51224-206-50) | 2013-09-23 | 2027-11-30 | No | No | Current |