APADAZ
- Product NDC
- 70040-0189
- 11-digit product format
- 700400189
- Labeler code
- 70040
- Product ID
- 70040-0189_29a56d99-ac58-69d0-e063-6394a90a32a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzhydrocodone and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zevra Therapeutics, Inc.
- Application
- NDA208653
- Marketing category
- NDA
- Marketing start
- 2018-02-23
- Substance
- ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
- Active strength
- 325; 8.16 mg/1; mg/1
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- APADAZ
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| BENZHYDROCODONE HYDROCHLORIDE | 8.16 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | I894QAU7FJ, 362O9ITL9D |
| Rxcui | 2001358, 2001364, 2118728, 2118730, 2118732, 2118734 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70040-0189-1 | APADAZ | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70040-0189 | APADAZ (BENZHYDROCODONE AND ACETAMINOPHEN) TABLET [ZEVRA THERAPEUTICS, INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20250108_0590d4e5-7107-4015-a6a8-deac14265aa2.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2118730 | apadaz 4.08 MG / 325 MG Oral Tablet | PSN | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2001364 | apadaz 6.12 MG / 325 MG Oral Tablet | PSN | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2118734 | apadaz 8.16 MG / 325 MG Oral Tablet | PSN | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2118728 | benzhydrocodone 4.08 MG / acetaminophen 325 MG Oral Tablet | PSN | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2118732 | benzhydrocodone 8.16 MG / acetaminophen 325 MG Oral Tablet | PSN | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2001358 | benzyhydrocodone 6.12 MG / acetaminophen 325 MG Oral Tablet | PSN | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2118730 | acetaminophen 325 MG / benzhydrocodone 4.08 MG Oral Tablet [Apadaz] | SBD | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2001364 | acetaminophen 325 MG / benzhydrocodone 6.12 MG Oral Tablet [Apadaz] | SBD | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2118734 | acetaminophen 325 MG / benzhydrocodone 8.16 MG Oral Tablet [Apadaz] | SBD | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2118728 | acetaminophen 325 MG / benzhydrocodone 4.08 MG Oral Tablet | SCD | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2001358 | acetaminophen 325 MG / benzhydrocodone 6.12 MG Oral Tablet | SCD | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2118732 | acetaminophen 325 MG / benzhydrocodone 8.16 MG Oral Tablet | SCD | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2001358 | acetaminophen 325 MG / benzhydrocodone 6.12 MG (as benzhydrocodone HCl 6.67 MG) Oral Tablet | SY | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2118732 | acetaminophen 325 MG / benzhydrocodone 8.16 MG (as benzhydrocodone HCl 8.9 MG) Oral Tablet | SY | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2118730 | Apadaz 4.08 MG / 325 MG Oral Tablet | SY | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2001364 | Apadaz 6.12 MG / 325 MG Oral Tablet | SY | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2118734 | Apadaz 8.16 MG / 325 MG Oral Tablet | SY | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2118728 | APAP 325 MG / benzhydrocodone 4.08 MG Oral Tablet | SY | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2118730 | APAP 325 MG / benzhydrocodone 4.08 MG Oral Tablet [Apadaz] | SY | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2001358 | APAP 325 MG / benzhydrocodone 6.12 MG Oral Tablet | SY | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2001364 | APAP 325 MG / benzhydrocodone 6.12 MG Oral Tablet [Apadaz] | SY | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2118732 | APAP 325 MG / benzhydrocodone 8.16 MG Oral Tablet | SY | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
| 2118734 | APAP 325 MG / benzhydrocodone 8.16 MG Oral Tablet [Apadaz] | SY | 0590d4e5-7107-4015-a6a8-deac14265aa2 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70040-0189-1 | 70040018901 | 100 TABLET in 1 BOTTLE, PLASTIC (70040-0189-1) | 100 tablet | 2018-02-23 | No | No | Current |