Oxycodone Hydrochloride
- Product NDC
- 63629-1928
- Requested package NDC
- 63629-1928-1
- 11-digit product format
- 636291928
- Labeler code
- 63629
- Product ID
- 63629-1928_4f035c1e-1131-469b-9e3a-c939de1b360f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA207418
- Marketing category
- ANDA
- Marketing start
- 2017-08-08
- Marketing end
- 0000-00-00
- Substance
- OXYCODONE HYDROCHLORIDE
- Active strength
- 15 mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 | 63629-1928 | 63629-1928-1 | D | Discontinued by firm | 2026-08-17 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207418-001 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | |
| A207418-002 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | |
| A207418-003 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2025-11-14 | |
| A207418-004 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2025-11-14 | |
| A207418-005 | OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2025-11-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A207418-001 | AB |
| A207418-002 | AB |
| A207418-003 | AB |
| A207418-004 | AB |
| A207418-005 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207418-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2025-11-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207418-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2025-11-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A207418-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2025-11-14 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207418-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2025-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207418-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2025-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A207418-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2025-11-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207418-003 | OXYCODONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2025-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207418-004 | OXYCODONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2025-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207418-005 | OXYCODONE HYDROCHLORIDE | 20MG | TABLET / ORAL | AB | 2025-11-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A207418-002 | OXYCODONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2017-08-07 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207418-001 | OXYCODONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2017-08-07 | 5c6f7cd8ea54… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A207418-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207418-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207418-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207418-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A207418-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A207418-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207418-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207418-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207418-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A207418-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207418-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207418-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207418-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207418-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207418-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A207418-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A207418-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207418-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207418-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207418-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207418-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207418-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207418-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207418-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207418-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207418-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207418-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207418-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207418-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A207418-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A207418-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207418-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207418-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207418-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207418-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207418-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207418-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A207418-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A207418-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207418-001 | AB | 1 | 5c6f7cd8ea54… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-1928-1 | EA - Each | 63629-1928 | 2a298039-e735-44c7-8040-dde77dcda346 | 1 | 2021-03-02 |
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 |
|---|---|---|---|---|---|---|
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 585405bc-8b85-286f-e063-6394a90aa5cd | 2026-08-06 | Boxed warning, Warnings, Adverse reactions | 207418 ANDA207418 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 57afed61-79db-ca43-e063-6394a90a68eb | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 207418 ANDA207418 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 27124cdf-a3e8-474c-9c1e-6fa48f6ddc05 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | 207418 ANDA207418 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | ff7f1268-ddb7-4742-beee-8b12966fe8f9 | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | 207418 ANDA207418 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Bryant Ranch Prepack | 35030c55-47e6-44cb-9d96-0c3cd5d0c238 | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | 207418 ANDA207418 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | Camber Pharmaceuticals Inc | 01db4606-d49c-4b10-a78a-1cf41880a9fb | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 207418 ANDA207418 |
| Oxycodone Hydrochloride | OXYCODONE HYDROCHLORIDE | XLCare Pharmaceuticals, Inc | e5c8e72d-4ac5-4ca3-9557-6a659d4d8338 | 2021-05-28 | Boxed warning, Warnings, Adverse reactions | 207418 ANDA207418 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-1928-1 | 63629192801 | 500 TABLET in 1 BOTTLE (63629-1928-1) | 500 tablet | 2017-08-08 | 0000-00-00 | No | No | Current |