Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 71930-027
- 11-digit product format
- 719300027
- Labeler code
- 71930
- Product ID
- 71930-027_5ab6fc05-d708-4f00-9336-33a541bf0c87
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Eywa Pharma Inc
- Application
- ANDA211023
- Marketing category
- ANDA
- Marketing start
- 2019-04-08
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 7.5 mg/15mL; mg/15mL
- 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 and Acetaminophen
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/15mL |
| HYDROCODONE BITARTRATE | 7.5 mg/15mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, NO70W886KK |
| Rxcui | 856940 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71930-027-43 | Hydrocodone Bitartrate and Acetaminophen | 473 mL in 1 BOTTLE | SOLUTION | 473 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71930-027-43 | ML - Milliliter | 71930-027 | c809d352-d6de-4dd0-997b-4562ff959fce | 1 | 2019-05-02 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 856940 | HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG in 15 mL Oral Solution | PSN | f55d0cc9-996e-49c2-b8c1-acaceac99afe | 6 |
| 856940 | acetaminophen 21.7 MG/ML / hydrocodone bitartrate 0.5 MG/ML Oral Solution | SCD | f55d0cc9-996e-49c2-b8c1-acaceac99afe | 6 |
| 856940 | acetaminophen 108 MG / hydrocodone bitartrate 2.5 MG per 5 ML Oral Solution | SY | f55d0cc9-996e-49c2-b8c1-acaceac99afe | 6 |
| 856940 | acetaminophen 217 MG / hydrocodone bitartrate 5 MG per 10 ML Oral Solution | SY | f55d0cc9-996e-49c2-b8c1-acaceac99afe | 6 |
| 856940 | acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG per 15 ML Oral Solution | SY | f55d0cc9-996e-49c2-b8c1-acaceac99afe | 6 |
| 856940 | APAP 21.7 MG/ML / Hydrocodone Bitartrate 0.5 MG/ML Oral Solution | SY | f55d0cc9-996e-49c2-b8c1-acaceac99afe | 6 |
| 856940 | HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG in 15 mL Oral Solution | PSN | 37451478-b961-873b-e063-6394a90a7b4e | 4 |
| 856940 | acetaminophen 21.7 MG/ML / hydrocodone bitartrate 0.5 MG/ML Oral Solution | SCD | 37451478-b961-873b-e063-6394a90a7b4e | 4 |
| 856940 | acetaminophen 108 MG / hydrocodone bitartrate 2.5 MG per 5 ML Oral Solution | SY | 37451478-b961-873b-e063-6394a90a7b4e | 4 |
| 856940 | acetaminophen 217 MG / hydrocodone bitartrate 5 MG per 10 ML Oral Solution | SY | 37451478-b961-873b-e063-6394a90a7b4e | 4 |
| 856940 | acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG per 15 ML Oral Solution | SY | 37451478-b961-873b-e063-6394a90a7b4e | 4 |
| 856940 | APAP 21.7 MG/ML / Hydrocodone Bitartrate 0.5 MG/ML Oral Solution | SY | 37451478-b961-873b-e063-6394a90a7b4e | 4 |
| 856940 | HYDROcodone bitartrate 7.5 MG / acetaminophen 325 MG in 15 mL Oral Solution | PSN | adb37532-aa19-48a2-95a1-8c92a6ce8651 | 3 |
| 856940 | acetaminophen 21.7 MG/ML / hydrocodone bitartrate 0.5 MG/ML Oral Solution | SCD | adb37532-aa19-48a2-95a1-8c92a6ce8651 | 3 |
| 856940 | acetaminophen 108 MG / hydrocodone bitartrate 2.5 MG per 5 ML Oral Solution | SY | adb37532-aa19-48a2-95a1-8c92a6ce8651 | 3 |
| 856940 | acetaminophen 217 MG / hydrocodone bitartrate 5 MG per 10 ML Oral Solution | SY | adb37532-aa19-48a2-95a1-8c92a6ce8651 | 3 |
| 856940 | acetaminophen 325 MG / hydrocodone bitartrate 7.5 MG per 15 ML Oral Solution | SY | adb37532-aa19-48a2-95a1-8c92a6ce8651 | 3 |
| 856940 | APAP 21.7 MG/ML / Hydrocodone Bitartrate 0.5 MG/ML Oral Solution | SY | adb37532-aa19-48a2-95a1-8c92a6ce8651 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71930-027-43 | 71930002743 | 473 mL in 1 BOTTLE (71930-027-43) | 473 ml | 2019-04-08 | 0000-00-00 | No | No | Current |