Hydrocodone Bitartrate
- Product NDC
- 47781-396
- 11-digit product format
- 477810396
- Labeler code
- 47781
- Product ID
- 47781-396_271ec71a-ed16-53cb-f7a8-8d10949ec504
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alvogen Inc.
- Application
- ANDA208269
- Marketing category
- ANDA
- Marketing start
- 2021-03-03
- Substance
- HYDROCODONE BITARTRATE
- Active strength
- 80 mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- 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
- Hydrocodone Bitartrate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCODONE BITARTRATE | 80 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NO70W886KK |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47781-396-60 | Hydrocodone Bitartrate | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47781-396 | HYDROCODONE BITARTRATE TABLET, EXTENDED RELEASE [ALVOGEN INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240612_f7b55d14-0980-b680-8ceb-7489ff65455e.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1595764 | HYDROcodone bitartrate 100 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent | PSN | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
| 1595770 | HYDROcodone bitartrate 120 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent | PSN | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
| 1595730 | HYDROcodone bitartrate 20 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent | PSN | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
| 1595740 | HYDROcodone bitartrate 30 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent | PSN | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
| 1595746 | HYDROcodone bitartrate 40 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent | PSN | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
| 1595752 | HYDROcodone bitartrate 60 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent | PSN | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
| 1595758 | HYDROcodone bitartrate 80 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent | PSN | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
| 1595764 | Abuse-Deterrent 24 HR hydrocodone bitartrate 100 MG Extended Release Oral Tablet | SCD | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
| 1595770 | Abuse-Deterrent 24 HR hydrocodone bitartrate 120 MG Extended Release Oral Tablet | SCD | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
| 1595730 | Abuse-Deterrent 24 HR hydrocodone bitartrate 20 MG Extended Release Oral Tablet | SCD | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
| 1595740 | Abuse-Deterrent 24 HR hydrocodone bitartrate 30 MG Extended Release Oral Tablet | SCD | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
| 1595746 | Abuse-Deterrent 24 HR hydrocodone bitartrate 40 MG Extended Release Oral Tablet | SCD | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
| 1595752 | Abuse-Deterrent 24 HR hydrocodone bitartrate 60 MG Extended Release Oral Tablet | SCD | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
| 1595758 | Abuse-Deterrent 24 HR hydrocodone bitartrate 80 MG Extended Release Oral Tablet | SCD | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
| 1595764 | hydrocodone bitartrate 100 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent | SY | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
| 1595770 | hydrocodone bitartrate 120 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent | SY | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
| 1595730 | hydrocodone bitartrate 20 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent | SY | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
| 1595740 | hydrocodone bitartrate 30 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent | SY | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
| 1595746 | hydrocodone bitartrate 40 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent | SY | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
| 1595752 | hydrocodone bitartrate 60 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent | SY | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
| 1595758 | hydrocodone bitartrate 80 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent | SY | f7b55d14-0980-b680-8ceb-7489ff65455e | 8 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 47781-396-60 | 47781039660 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-396-60) | 2021-03-03 | 0000-00-00 | No | No | Current |