METHADONE HYDROCHLORIDE
- Product NDC
- 52959-386
- 11-digit product format
- 529590386
- Labeler code
- 52959
- Product ID
- 52959-386_8a7832fd-a24f-43b5-b46c-6043dfb24114
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHADONE HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- H.J. Harkins Company Inc.
- Application
- ANDA040517
- Marketing category
- ANDA
- Marketing start
- 2009-05-19
- Marketing end
- 0000-00-00
- Substance
- METHADONE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52959-386-02 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d1e4-f6ea-e053-dbdaa90aa703 | METHADONE HYDROCHLORIDE TABLETS USP 5 mg, 10 mg CII Rx only |
| 52959-386-30 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d1e4-f6ea-e053-dbdaa90aa703 | METHADONE HYDROCHLORIDE TABLETS USP 5 mg, 10 mg CII Rx only |
| 52959-386-60 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d1e4-f6ea-e053-dbdaa90aa703 | METHADONE HYDROCHLORIDE TABLETS USP 5 mg, 10 mg CII Rx only |
| 52959-386-90 | 2019-11-13 | C162847 | 48780-1 | 97449f38-d1e4-f6ea-e053-dbdaa90aa703 | METHADONE HYDROCHLORIDE TABLETS USP 5 mg, 10 mg CII Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52959-386-02 | METHADONE HYDROCHLORIDE | 120 in 1 BOTTLE | TABLET | 120 | 3 | |
| 52959-386-30 | METHADONE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 52959-386-60 | METHADONE HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET | 60 | 3 | |
| 52959-386-90 | METHADONE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET | 90 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52959-386-02 | EA - Each | 52959-386 | 691de44f-cb34-4031-8408-a08fc1c1e208 | 1 | 2012-07-24 |
| 52959-386-30 | EA - Each | 52959-386 | 6c3d8898-7777-42f2-b7c7-0e88e5ce25b3 | 1 | 2012-07-24 |
| 52959-386-60 | EA - Each | 52959-386 | f728ec4d-8695-4741-8730-e7fc8f3b4f07 | 1 | 2012-07-24 |
| 52959-386-90 | EA - Each | 52959-386 | 348c0e2a-d9af-4885-9a77-e3c67dddda28 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE | ACTIVE INGREDIENT | 229809935B | METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.] | 3 | |
| METHADONE | ACTIVE MOIETY | UC6VBE7V1Z | METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 864706 | methadone HCl 10 MG Oral Tablet | PSN | 3c926b78-999e-4d26-9498-7f1bcaf0b992 | 3 |
| 864718 | methadone HCl 5 MG Oral Tablet | PSN | 3c926b78-999e-4d26-9498-7f1bcaf0b992 | 3 |
| 864706 | methadone hydrochloride 10 MG Oral Tablet | SCD | 3c926b78-999e-4d26-9498-7f1bcaf0b992 | 3 |
| 864718 | methadone hydrochloride 5 MG Oral Tablet | SCD | 3c926b78-999e-4d26-9498-7f1bcaf0b992 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 52959-386-02 | 52959038602 | 120 in 1 BOTTLE | Historical |
| 52959-386-30 | 52959038630 | 30 in 1 BOTTLE | Historical |
| 52959-386-60 | 52959038660 | 60 in 1 BOTTLE | Historical |
| 52959-386-90 | 52959038690 | 90 in 1 BOTTLE | Historical |