Oxycodone and Acetaminophen
- Product NDC
- 10702-187
- 11-digit product format
- 107020187
- Labeler code
- 10702
- Product ID
- 10702-187_5104be8c-6b64-f19a-e063-6294a90ac130
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxycodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- KVK-Tech, Inc.
- Application
- ANDA210644
- Marketing category
- ANDA
- Marketing start
- 2018-02-09
- Substance
- ACETAMINOPHEN; OXYCODONE
- Active strength
- 325; 10 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210644-001 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;2.5MG | TABLET / ORAL | AA | 2018-02-09 | |
| A210644-002 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET / ORAL | AA | 2018-02-09 | |
| A210644-003 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET / ORAL | AA | 2018-02-09 | |
| A210644-004 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET / ORAL | AA | 2018-02-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210644-001 | AA |
| A210644-002 | AA |
| A210644-003 | AA |
| A210644-004 | 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 | A210644-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2018-02-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210644-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-02-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210644-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-02-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210644-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-02-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210644-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2018-02-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210644-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-02-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210644-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-02-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210644-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-02-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210644-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2018-02-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210644-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-02-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210644-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-02-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210644-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-02-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210644-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2018-02-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210644-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-02-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210644-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-02-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210644-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-02-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210644-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2018-02-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210644-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-02-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210644-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-02-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210644-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-02-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210644-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2018-02-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210644-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-02-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210644-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-02-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210644-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-02-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210644-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2018-02-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210644-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-02-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210644-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-02-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210644-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-02-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210644-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2018-02-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210644-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-02-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210644-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-02-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210644-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-02-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210644-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2018-02-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210644-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-02-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210644-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-02-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210644-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-02-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210644-001 | OXYCODONE AND ACETAMINOPHEN | 325MG;2.5MG | TABLET / ORAL | AA | 2018-02-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210644-002 | OXYCODONE AND ACETAMINOPHEN | 325MG;5MG | TABLET / ORAL | AA | 2018-02-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210644-003 | OXYCODONE AND ACETAMINOPHEN | 325MG;7.5MG | TABLET / ORAL | AA | 2018-02-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210644-004 | OXYCODONE AND ACETAMINOPHEN | 325MG;10MG | TABLET / ORAL | AA | 2018-02-09 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210644-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210644-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210644-003 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210644-004 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210644-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210644-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210644-003 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210644-004 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210644-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210644-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210644-003 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210644-004 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210644-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210644-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210644-003 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210644-004 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210644-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210644-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210644-003 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210644-004 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210644-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210644-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210644-003 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210644-004 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210644-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210644-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210644-003 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210644-004 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210644-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210644-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210644-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210644-004 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210644-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210644-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210644-003 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210644-004 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210644-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210644-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210644-003 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210644-004 | AA | 1 | d06236e962d9… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oxycodone and Acetaminophen
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OXYCODONE | 325 mg/1 |
| ACETAMINOPHEN | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| CD35PMG570 | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f9cf218c-af5e-4249-aa3b-a8555ed02278 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10702-187-01 | Oxycodone and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | 21 | |
| 10702-187-10 | Oxycodone and Acetaminophen | 1000 in 1 BOTTLE | TABLET | 1000 | 21 | |
| 10702-187-50 | Oxycodone and Acetaminophen | 500 in 1 BOTTLE | TABLET | 500 | 21 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10702-187-01 | EA - Each | 10702-187 | 1c6f2999-419a-43c7-8cd8-c2182865f0bd | 1 | 2018-05-09 |
| 10702-187-50 | EA - Each | 10702-187 | 84c7d538-ae19-4c38-8571-969234f92f22 | 1 | 2018-10-11 |
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 and Acetaminophen | OXYCODONE AND ACETAMINOPHEN | KVK-Tech, Inc. | f9cf218c-af5e-4249-aa3b-a8555ed02278 | 2026-05-04 | Boxed warning, Warnings, Adverse reactions | 210644 ANDA210644 10702-187 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049214 | oxyCODONE 10 MG / acetaminophen 325 MG Oral Tablet | PSN | f9cf218c-af5e-4249-aa3b-a8555ed02278 | 21 |
| 1049221 | oxyCODONE 5 MG / acetaminophen 325 MG Oral Tablet | PSN | f9cf218c-af5e-4249-aa3b-a8555ed02278 | 21 |
| 1049225 | oxyCODONE 7.5 MG / acetaminophen 325 MG Oral Tablet | PSN | f9cf218c-af5e-4249-aa3b-a8555ed02278 | 21 |
| 1049635 | oxyCODONE HCl 2.5 MG / acetaminophen 325 MG Oral Tablet | PSN | f9cf218c-af5e-4249-aa3b-a8555ed02278 | 21 |
| 1049214 | acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral Tablet | SCD | f9cf218c-af5e-4249-aa3b-a8555ed02278 | 21 |
| 1049635 | acetaminophen 325 MG / oxycodone hydrochloride 2.5 MG Oral Tablet | SCD | f9cf218c-af5e-4249-aa3b-a8555ed02278 | 21 |
| 1049221 | acetaminophen 325 MG / oxycodone hydrochloride 5 MG Oral Tablet | SCD | f9cf218c-af5e-4249-aa3b-a8555ed02278 | 21 |
| 1049225 | acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet | SCD | f9cf218c-af5e-4249-aa3b-a8555ed02278 | 21 |
| 1049214 | APAP 325 MG / oxycodone hydrochloride 10 MG Oral Tablet | SY | f9cf218c-af5e-4249-aa3b-a8555ed02278 | 21 |
| 1049635 | APAP 325 MG / Oxycodone Hydrochloride 2.5 MG Oral Tablet | SY | f9cf218c-af5e-4249-aa3b-a8555ed02278 | 21 |
| 1049221 | APAP 325 MG / oxycodone hydrochloride 5 MG Oral Tablet | SY | f9cf218c-af5e-4249-aa3b-a8555ed02278 | 21 |
| 1049225 | APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral Tablet | SY | f9cf218c-af5e-4249-aa3b-a8555ed02278 | 21 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 10702-187-01 | 10702018701 | 100 TABLET in 1 BOTTLE (10702-187-01) | 100 tablet | 2018-02-09 | 0000-00-00 | No | No | Current |
| 10702-187-10 | 10702018710 | 1000 TABLET in 1 BOTTLE (10702-187-10) | 1000 tablet | 2018-02-09 | 0000-00-00 | No | No | Current |
| 10702-187-50 | 10702018750 | 500 TABLET in 1 BOTTLE (10702-187-50) | 500 tablet | 2018-02-09 | 0000-00-00 | No | No | Current |