Prescription drug · NDA
Apadaz (Benzhydrocodone and acetaminophen) NDC 70040-0189
Benzhydrocodone hydrochloride 8.16 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · Zevra Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70040-0189-1 | 70040018901 | 100 TABLET in 1 BOTTLE, PLASTIC (70040-0189-1)Marketed from Feb 23, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Apadaz
- Generic name (nonproprietary)
- benzhydrocodone and acetaminophen
- Active ingredients
- Benzhydrocodone hydrochloride — 8.16 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Zevra Therapeutics, Inc.NDC labeler code 70040
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208653
- Marketing start
- Listing expires
- DEA schedule
- CII
- Identifiers
- Product ID 70040-0189_29a56d99-ac58-69d0-e063-6394a90a32a0SPL ID 29a56d99-ac58-69d0-e063-6394a90a32a0SPL set ID 0590d4e5-7107-4015-a6a8-deac14265aa2RxCUI 2001358, 2001364, 2118728, 2118730, 2118732, 2118734UNII 362O9ITL9D, I894QAU7FJ
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470040018901followed by a unit qualifier and the quantityPackage 70040-0189-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
APADAZ is indicated for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions ( 5.1 ) ] reserve APADAZ for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia. APADAZ should not be used for an extended period of time unless the pain remains severe enoug…
Excerpt only. Read the full label for complete information.
About NDC 70040-0189
- What is NDC 70040-0189?
- 70040-0189 is the product NDC for Apadaz, Benzhydrocodone hydrochloride 8.16 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Zevra Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Apadaz (Benzhydrocodone and Acetaminophen).
- What is the active ingredient?
- Benzhydrocodone hydrochloride, Acetaminophen.
- Who is the labeler?
- Zevra Therapeutics, Inc., NDC labeler code 70040. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Apadaz?
- 2 other product NDCs are listed under this name. See all Apadaz NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Apadaz products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Apadazbenzhydrocodone and acetaminophen | Benzhydrocodone hydrochloride 4.08 mg/1; Acetaminophen 325 mg/1 | TabletOral | Zevra Therapeutics, Inc. | 70040-0145 | 70040-0145-01 |
| Apadazbenzhydrocodone and acetaminophen | Benzhydrocodone hydrochloride 6.12 mg/1; Acetaminophen 325 mg/1 | TabletOral | Zevra Therapeutics, Inc. | 70040-0167 | 70040-0167-01 |
Other NDCs under NDA 208653
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Apadazbenzhydrocodone and acetaminophen | Benzhydrocodone hydrochloride 4.08 mg/1; Acetaminophen 325 mg/1 | TabletOral | Zevra Therapeutics, Inc. | 70040-0145 |
| Apadazbenzhydrocodone and acetaminophen | Benzhydrocodone hydrochloride 6.12 mg/1; Acetaminophen 325 mg/1 | TabletOral | Zevra Therapeutics, Inc. | 70040-0167 |