Prescription drug · ANDA
Hydrocodone Bitartrate And Acetaminophen NDC 72189-343
Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · Direct Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-343-08 | 7218903430872189034308 | 8 TABLET in 1 BOTTLE (72189-343-08)Marketed from Sep 22, 2022 | |
| 72189-343-20 | 7218903432072189034320 | 20 TABLET in 1 BOTTLE (72189-343-20)Marketed from Mar 30, 2022 | |
| 72189-343-30 | 7218903433072189034330 | 30 TABLET in 1 BOTTLE (72189-343-30)Marketed from Mar 30, 2022 | |
| 72189-343-60 | 7218903436072189034360 | 60 TABLET in 1 BOTTLE (72189-343-60)Marketed from Mar 30, 2022 | |
| 72189-343-72 | 7218903437272189034372 | 120 TABLET in 1 BOTTLE (72189-343-72)Marketed from Mar 30, 2022 | |
| 72189-343-90 | 7218903439072189034390 | 90 TABLET in 1 BOTTLE (72189-343-90)Marketed from Mar 30, 2022 |
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 — 5 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Direct RxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211487
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 72189-343_2eaccf77-5ca1-97e7-e063-6394a90a7c39SPL ID 2eaccf77-5ca1-97e7-e063-6394a90a7c39SPL set ID db73b8ed-9747-6a49-e053-2a95a90a93a1RxCUI 857002UNII 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
N472189034308followed by a unit qualifier and the quantityPackage 72189-0343-08. 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 .
Indications (excerpt from the label)
Hydrocodone bitartrate and acetaminophen tablets, USP 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, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve hydrocodone bitartrate and acetaminophen tablets, USP 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
Excerpt only. Read the full label for complete information.
About NDC 72189-343
- What is NDC 72189-343?
- 72189-343 is the product NDC for Hydrocodone Bitartrate And Acetaminophen, Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Direct Rx. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Hydrocodone Bitartrate And Acetaminophen.
- What is the active ingredient?
- Hydrocodone bitartrate, Acetaminophen.
- Who is the labeler?
- Direct Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Hydrocodone Bitartrate And Acetaminophen?
- 201 other product NDCs are listed under this name. See all Hydrocodone Bitartrate And Acetaminophen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Hydrocodone Bitartrate And Acetaminophen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-873 | 60760-0873-3060760-0873-60 |
| Hydrocodone Bitartrate and Acetaminophen | Acetaminophen 325 mg/1; Hydrocodone bitartrate 10 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-872 | 60760-0872-3060760-0872-60 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-442 | 64380-0442-01 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-440 | 64380-0440-01 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-441 | 64380-0441-01 |
| hydrocodone bitartrate and acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Proficient Rx LP | 82804-306 | 82804-0306-12 |
| Hydrocodone Bitartrate And Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-870 | 60760-0870-3060760-0870-60 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 2.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-940 | 31722-0940-01 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-942 | 31722-0942-0131722-0942-05 |
| Hydrocodone Bitartrate And Acetaminophen | Hydrocodone bitartrate 10 mg/15mL; Acetaminophen 300 mg/15mL | LiquidOral | Hikma Pharmaceuticals USA Inc. | 0054-0843 | 00054-0843-63 |
Other NDCs under ANDA 211487
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 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9602 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2195 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-110 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 2.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-109 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-111 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-112 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 2.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-940 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-204 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-942 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 2.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-201 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-202 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-203 |
| Hydrocodone Bitartrate And Acetaminophen | Acetaminophen 325 mg/1; Hydrocodone bitartrate 10 mg/1 | TabletOral | DirectRx | 72189-348 |
| Hydrocodone APAP | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Direct_Rx | 72189-352 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-996 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-997 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2104 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2103 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2105 |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2112 |
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