NDC 42549-578 - METHADONE HYDROCHLORIDE
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 42549-578
- Package NDCs from labels
- 42549-578-02, 42549-578-08, 42549-578-28, 42549-578-30, 42549-578-56, 42549-578-60
- Manufacturer
- STAT Rx USA LLC | PSS World Medical Inc.
- Effective date
- 2012-04-20
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| METHADONE HYDROCHLORIDE TABLETS USP 5 mg, 10 mg CII Rx only | STAT Rx USA LLC | PSS World Medical Inc. | 2012-04-20 | HUMAN PRESCRIPTION DRUG LABEL |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42549-578-02 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c79d-f6ea-e053-dbdaa90aa703 | METHADONE HYDROCHLORIDE TABLETS USP 5 mg, 10 mg CII Rx only |
| 42549-578-08 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c79d-f6ea-e053-dbdaa90aa703 | METHADONE HYDROCHLORIDE TABLETS USP 5 mg, 10 mg CII Rx only |
| 42549-578-28 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c79d-f6ea-e053-dbdaa90aa703 | METHADONE HYDROCHLORIDE TABLETS USP 5 mg, 10 mg CII Rx only |
| 42549-578-30 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c79d-f6ea-e053-dbdaa90aa703 | METHADONE HYDROCHLORIDE TABLETS USP 5 mg, 10 mg CII Rx only |
| 42549-578-56 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c79d-f6ea-e053-dbdaa90aa703 | METHADONE HYDROCHLORIDE TABLETS USP 5 mg, 10 mg CII Rx only |
| 42549-578-60 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c79d-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 |
|---|---|---|---|---|---|---|
| 42549-578-02 | METHADONE HYDROCHLORIDE | 112 in 1 BOTTLE | TABLET | 112 | 1 | |
| 42549-578-08 | METHADONE HYDROCHLORIDE | 168 in 1 BOTTLE | TABLET | 168 | 1 | |
| 42549-578-28 | METHADONE HYDROCHLORIDE | 28 in 1 BOTTLE | TABLET | 28 | 1 | |
| 42549-578-30 | METHADONE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 42549-578-56 | METHADONE HYDROCHLORIDE | 56 in 1 BOTTLE | TABLET | 56 | 1 | |
| 42549-578-60 | METHADONE HYDROCHLORIDE | 60 in 1 BOTTLE | TABLET | 60 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42549-578-02 | EA - Each | 42549-578 | 3c4419c6-6c4a-4aba-ad5d-9cb663771280 | 1 | 2012-07-24 |
| 42549-578-08 | EA - Each | 42549-578 | 6619ca9a-492c-4395-bb5a-70f03751ebbe | 1 | 2012-07-24 |
| 42549-578-28 | EA - Each | 42549-578 | 87bcdf87-b3c7-4713-8af0-db7544a433e2 | 1 | 2012-07-24 |
| 42549-578-30 | EA - Each | 42549-578 | e656cd35-3085-4fb1-ad52-63b3eab26286 | 1 | 2012-07-24 |
| 42549-578-56 | EA - Each | 42549-578 | 058db91c-d969-438a-be39-79015041368c | 1 | 2012-07-24 |
| 42549-578-60 | EA - Each | 42549-578 | e0449e48-5c6a-4c02-8044-46f3d37bf38d | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METHADONE HYDROCHLORIDE | ACTIVE INGREDIENT | 229809935B | METHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC] | 1 | |
| METHADONE | ACTIVE MOIETY | UC6VBE7V1Z | METHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | METHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | METHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | METHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | METHADONE HYDROCHLORIDE TABLET [STAT RX USA LLC] | 1 |