Methadone Hydrochloride
- Product NDC
- 0054-3553
- 11-digit product format
- 000543553
- Labeler code
- 0054
- Product ID
- 0054-3553_f4843a89-4cfb-40de-8399-a7449b4865e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methadone Hydrochloride
- Dosage form
- CONCENTRATE
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA089897
- Marketing category
- ANDA
- Marketing start
- 1988-09-06
- Substance
- METHADONE HYDROCHLORIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bc6c52c8-e3e2-9042-21d0-6770dcf1a49b | Product name | 3 | 20250819 |
| a48f0261-b6cc-12b3-49fd-ed131bc5aa96 | Product name | 4 | 20210902 |
| 00dcb24c-d95e-78f6-6c1b-4d7b709bb2b9 | Product name | 6 | 20200708 |
| a6a96832-f31d-b458-45cb-abb8bd940b44 | Product name | 2 | 20200304 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0054-3553-44 | Methadone Hydrochloride | 30 mL in 1 BOTTLE | CONCENTRATE | 30 | 11 | |
| 0054-3553-44 | Methadone Hydrochloride | 1 in 1 CARTON | CONCENTRATE | 1 | 11 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0054-3553-44 | ML - Milliliter | 0054-3553 | 7f20c4b7-99db-4bd1-ae7e-a8fd16c0ce28 | 1 | 2013-02-11 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE | ACTIVE INGREDIENT | 229809935B | METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC] | 4 | |
| METHADONE | ACTIVE MOIETY | UC6VBE7V1Z | METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC] | 4 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC] | 4 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | METHADONE HYDROCHLORIDE CONCENTRATE [ROXANE LABORATORIES, INC] | 4 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 991147 | methadone HCl 10 MG in 1 mL Concentrate for Oral Solution | PSN | d0e6a966-179a-45e0-8444-4c1b8523f8d2 | 11 |
| 991147 | methadone hydrochloride 10 MG/ML Oral Solution | SCD | d0e6a966-179a-45e0-8444-4c1b8523f8d2 | 11 |
| 991147 | methadone hydrochloride 10 MG per 1 ML Oral Solution | SY | d0e6a966-179a-45e0-8444-4c1b8523f8d2 | 11 |
| 991147 | methadone hydrochloride 5 MG per 0.5 ML Oral Solution | SY | d0e6a966-179a-45e0-8444-4c1b8523f8d2 | 11 |
| 991147 | methadone HCl 10 MG in 1 mL Concentrate for Oral Solution | PSN | 52bea06c-6c93-4458-a79b-c3eb3a9166b6 | 1 |
| 991147 | methadone hydrochloride 10 MG/ML Oral Solution | SCD | 52bea06c-6c93-4458-a79b-c3eb3a9166b6 | 1 |
| 991147 | methadone hydrochloride 10 MG per 1 ML Oral Solution | SY | 52bea06c-6c93-4458-a79b-c3eb3a9166b6 | 1 |
| 991147 | methadone hydrochloride 5 MG per 0.5 ML Oral Solution | SY | 52bea06c-6c93-4458-a79b-c3eb3a9166b6 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0054-3553-44 | 00054355344 | 1 BOTTLE in 1 CARTON (0054-3553-44) / 30 mL in 1 BOTTLE | 1 bottle | 1988-09-06 | 0000-00-00 | No | No | Current |