Prescription drug · ANDA
Hydrocodone Bitartrate and Acetaminophen NDC 10702-193
Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 300 mg/1 · Tablet · Oral · KVK-Tech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10702-193-01 | 10702019301 | 100 TABLET in 1 BOTTLE (10702-193-01)Marketed from Jun 22, 2017 | |
| 10702-193-03 | 10702019303 | 30 TABLET in 1 BOTTLE (10702-193-03)Marketed from Jun 22, 2017 | |
| 10702-193-10 | 10702019310 | 1000 TABLET in 1 BOTTLE (10702-193-10)Marketed from Jun 22, 2017 | |
| 10702-193-50 | 10702019350 | 500 TABLET in 1 BOTTLE (10702-193-50)Marketed from Jun 22, 2017 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Hydrocodone Bitartrate and Acetaminophen
- Generic name (nonproprietary)
- hydrocodone bitartrate and acetaminophen
- Active ingredients
- Hydrocodone bitartrate — 7.5 mg/1Acetaminophen — 300 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- KVK-Tech, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209036
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 10702-193_4a169a07-a8cd-ada4-e063-6394a90ac7d2SPL ID 4a169a07-a8cd-ada4-e063-6394a90ac7d2SPL set ID f1063950-b302-4898-81c2-b1626c9c16efRxCUI 856980, 856987, 856992, 856999, 857002, 857005UNII NO70W886KK, 362O9ITL9D
- Pharmacologic class
- Opioid Agonist
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
N410702019301followed by a unit qualifier and the quantityPackage 10702-0193-01. 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)
INDICATIONS AND USAGE Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of 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, misuse overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS ], reserve opioid analgesics, including hydrocodone bitartrate for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209036
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 |
|---|---|---|---|---|
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 300 mg/1 | TabletOral | KVK-Tech, Inc. | 10702-192 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 300 mg/1 | TabletOral | KVK-Tech, Inc. | 10702-194 |