Naltrexone Hydrochloride
- Product NDC
- 68094-853
- 11-digit product format
- 680940853
- Labeler code
- 68094
- Product ID
- 68094-853_7670a1a9-f14e-4e9e-8b3e-f8d5e52125e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- naltrexone Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Precision Dose Inc.
- Application
- ANDA075274
- Marketing category
- ANDA
- Marketing start
- 2014-10-29
- Substance
- NALTREXONE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Opioid Antagonist [EPC], Opioid Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naltrexone Hydrochloride
- Listing expiration
- 2026-12-31
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 |
|---|
| 68094-853-59 | Naltrexone Hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 6 |
| 68094-853-61 | Naltrexone Hydrochloride | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 6 |
| 68094-853-62 | Naltrexone Hydrochloride | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 6 |
| 68094-853-66 | Naltrexone Hydrochloride | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 6 |
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 | ACTIVE MOIETY | 5S6W795CQM | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE 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 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE 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 [PRECISION DOSE INC.] | 1 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] | 1 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68094-853 | NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20241017_74087d2f-468d-4de1-a2fc-a489d0f2abef.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68094-853-59 | 68094085359 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 68094-853-61 | 68094085361 | 10 BLISTER PACK in 1 CARTON (68094-853-61) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-853-59) | 10 blister pack | 2024-08-15 | | No | No | Historical |
| 68094-853-62 | 68094085362 | 3 BLISTER PACK in 1 CARTON (68094-853-62) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-853-59) | 3 blister pack | 2014-10-29 | 2026-12-31 | No | No | Current |
| 68094-853-66 | 68094085366 | 2 BLISTER PACK in 1 CARTON (68094-853-66) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-853-59) | 2 blister pack | 2024-08-15 | | No | No | Historical |