Methadone Hydrochloride
- Product NDC
- 0904-6530
- Requested package NDC
- 0904-6530-61
- 11-digit product format
- 009046530
- Labeler code
- 0904
- Product ID
- 0904-6530_9f353aee-c752-4c68-a915-60d987c85c57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methadone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA090635
- Marketing category
- ANDA
- Marketing start
- 2012-01-16
- 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
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0904-6530 | 0904-6530-61 | D | Discontinued by firm | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0904-6530 | 0904-6530-61 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0904-6530 | 0904-6530-61 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090635-001 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | |
| A090635-002 | METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AA | 2020-09-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090635-001 | AA |
| A090635-002 | AA |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090635-002 | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AA | 2020-09-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090635-002 | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AA | 2020-09-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090635-002 | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AA | 2020-09-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090635-002 | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AA | 2020-09-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090635-002 | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AA | 2020-09-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090635-002 | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AA | 2020-09-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090635-002 | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AA | 2020-09-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090635-002 | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AA | 2020-09-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090635-002 | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AA | 2020-09-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090635-002 | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AA | 2020-09-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090635-002 | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AA | 2020-09-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090635-002 | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AA | 2020-09-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090635-002 | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AA | 2020-09-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090635-002 | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AA | 2020-09-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090635-002 | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AA | 2020-09-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090635-002 | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AA | 2020-09-22 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090635-002 | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AA | 2020-09-22 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090635-002 | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AA | 2020-09-22 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090635-002 | METHADONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AA | 2020-09-22 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090635-001 | METHADONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AA | 2009-11-25 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090635-001 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090635-002 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090635-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090635-002 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090635-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090635-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090635-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090635-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090635-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090635-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090635-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090635-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090635-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090635-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090635-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090635-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090635-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090635-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090635-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090635-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090635-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090635-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090635-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090635-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090635-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090635-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090635-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090635-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090635-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090635-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090635-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090635-002 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090635-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090635-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090635-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090635-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090635-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090635-002 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090635-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090635-001 | AA | 1 | bb7c543d1eb4… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6530-60 | EA - Each | 0904-6530 | 38019e50-d916-4c8c-aeef-dba67c05d484 | 1 | 2016-03-04 |
| 0904-6530-61 | EA - Each | 0904-6530 | 88080714-8f86-433c-aa20-128217c7420b | 1 | 2016-10-06 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Methadone Hydrochloride | METHADONE HYDROCHLORIDE | Ascend Laboratories, LLC | f0366917-f745-4b01-a662-a98a7d80b4a0 | 2026-04-01 | Boxed warning, Warnings, Adverse reactions | 090635 ANDA090635 |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | Bryant Ranch Prepack | 7a8635fe-6183-4cda-9029-50e4e6dd5832 | 2023-11-06 | Boxed warning, Warnings, Adverse reactions | 090635 ANDA090635 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0904-6530-61 | 00904653061 | 100 BLISTER PACK in 1 CARTON (0904-6530-61) > 1 TABLET in 1 BLISTER PACK | 100 blister pack | 2012-01-16 | 0000-00-00 | No | No | Current |