Oxycodone Hydrochloride and Acetaminophen
- Product NDC
- 64850-621
- 11-digit product format
- 648500621
- Labeler code
- 64850
- Product ID
- 64850-621_523e66c8-fe6d-48c6-ab88-8c5eb25697b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone Hydrochloride and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Elite Laboratories, Inc.
- Application
- ANDA209385
- Marketing category
- ANDA
- Marketing start
- 2017-12-04
- Substance
- ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
- Active strength
- 325; 5 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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.
| Dataset | Scope | Package NDC |
|---|---|---|
| excluded product | product | |
| excluded package | package | 64850-621-60 |
| excluded package | package | 64850-621-30 |
| excluded package | package | 64850-621-90 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209385-001 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET / ORAL | AA | 2018-07-02 | |
| A209385-002 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET / ORAL | AA | 2018-07-02 | |
| A209385-003 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET / ORAL | AA | 2018-07-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209385-001 | AA |
| A209385-002 | AA |
| A209385-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209385-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-07-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209385-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-07-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209385-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-07-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209385-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-07-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209385-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-07-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209385-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-07-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209385-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-07-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209385-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-07-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209385-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-07-02 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209385-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-07-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209385-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-07-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209385-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-07-02 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209385-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-07-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209385-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-07-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209385-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-07-02 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209385-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-07-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209385-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-07-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209385-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-07-02 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209385-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-07-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209385-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-07-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209385-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-07-02 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209385-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-07-02 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209385-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-07-02 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209385-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-07-02 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209385-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-07-02 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209385-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-07-02 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209385-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-07-02 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209385-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-07-02 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209385-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-07-02 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209385-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-07-02 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209385-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2018-07-02 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209385-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2018-07-02 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209385-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2018-07-02 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209385-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2018-07-02 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209385-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2018-07-02 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209385-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2018-07-02 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209385-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2018-07-02 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209385-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | 2018-07-02 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209385-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | 2018-07-02 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209385-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | 2018-07-02 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209385-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209385-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209385-003 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209385-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209385-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209385-003 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209385-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209385-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209385-003 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209385-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209385-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209385-003 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209385-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209385-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209385-003 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209385-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209385-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209385-003 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209385-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209385-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209385-003 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209385-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209385-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209385-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209385-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209385-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209385-003 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209385-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209385-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209385-003 | AA | 1 | d06236e962d9… |
| 2019-12-13 00:20 UTC | 2019-12 | A209385-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A209385-002 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A209385-003 | AA | 1 | 74a2ff9319b5… |
| 2020-11-12 02:37 UTC | 2020-11 | A209385-001 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A209385-002 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A209385-003 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A209385-001 | AA | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A209385-002 | AA | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A209385-003 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A209385-001 | AA | 1 | b00525d2431f… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oxycodone Hydrochloride and Acetaminophen
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OXYCODONE HYDROCHLORIDE | 325 mg/1 |
| ACETAMINOPHEN | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| C1ENJ2TE6C | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 27fa8190-d334-4bb9-b277-d1f44db433e3 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64850-621-01 | Oxycodone Hydrochloride and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | 16 | |
| 64850-621-05 | Oxycodone Hydrochloride and Acetaminophen | 500 in 1 BOTTLE | TABLET | 500 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64850-621-01 | EA - Each | 64850-621 | 903dd3ae-0744-42b0-a163-b14b209a2d0c | 1 | 2025-05-14 |
| 64850-621-05 | EA - Each | 64850-621 | 25d23f94-5e0a-4f17-8038-33b6c880e359 | 1 | 2026-04-20 |
DailyMed Dashboard NDC Coverage#
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 and Acetaminophen | OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN | St. Mary's Medical Park Pharmacy | 40a882d6-a4db-1ad9-e063-6394a90a7268 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 209385 ANDA209385 |
| Oxycodone Hydrochloride and Acetaminophen | OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN | St. Mary's Medical Park Pharmacy | 40a68a27-4422-5ba0-e063-6294a90ac550 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 209385 ANDA209385 |
| Oxycodone Hydrochloride and Acetaminophen | OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN | St. Mary's Medical Park Pharmacy | 53de17b1-6d5b-c7c0-e063-6394a90a7064 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | 209385 ANDA209385 |
| Oxycodone Hydrochloride and Acetaminophen | OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN | Elite Laboratories, Inc. | 27fa8190-d334-4bb9-b277-d1f44db433e3 | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 209385 ANDA209385 64850-621 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049214 | oxyCODONE 10 MG / acetaminophen 325 MG Oral Tablet | PSN | 27fa8190-d334-4bb9-b277-d1f44db433e3 | 16 |
| 1049221 | oxyCODONE 5 MG / acetaminophen 325 MG Oral Tablet | PSN | 27fa8190-d334-4bb9-b277-d1f44db433e3 | 16 |
| 1049225 | oxyCODONE 7.5 MG / acetaminophen 325 MG Oral Tablet | PSN | 27fa8190-d334-4bb9-b277-d1f44db433e3 | 16 |
| 1049214 | acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet | SCD | 27fa8190-d334-4bb9-b277-d1f44db433e3 | 16 |
| 1049221 | acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral Tablet | SCD | 27fa8190-d334-4bb9-b277-d1f44db433e3 | 16 |
| 1049225 | acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet | SCD | 27fa8190-d334-4bb9-b277-d1f44db433e3 | 16 |
| 1049214 | APAP 325 MG / oxycodone hydrochloride 10 MG Oral Tablet | SY | 27fa8190-d334-4bb9-b277-d1f44db433e3 | 16 |
| 1049221 | APAP 325 MG / oxycodone hydrochloride 5 MG Oral Tablet | SY | 27fa8190-d334-4bb9-b277-d1f44db433e3 | 16 |
| 1049225 | APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet | SY | 27fa8190-d334-4bb9-b277-d1f44db433e3 | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 64850-621-01 | 64850062101 | 100 TABLET in 1 BOTTLE (64850-621-01) | 100 tablet | 2024-07-11 | No | No | Current |
| 64850-621-05 | 64850062105 | 500 TABLET in 1 BOTTLE (64850-621-05) | 500 tablet | 2026-04-09 | No | No | Current |