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NDC 58624-7012-00 Ibuprofen 200 mg/1 Details
Ibuprofen 200 mg/1
Ibuprofen is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Shandong Xinhua Pharmaceutical Co., Ltd.. The primary component is IBUPROFEN.
Product Information
| NDC | 58624-7012 |
|---|---|
| Product ID | 58624-7012_f6408497-ca24-228f-e053-2995a90ae91d |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Ibuprofen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ibuprofen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | IBUPROFEN |
| Labeler Name | Shandong Xinhua Pharmaceutical Co., Ltd. |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA207095 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 58624-7012-00 (58624701200)
| NDC Package Code | 58624-7012-0 |
|---|---|
| Billing NDC | 58624701200 |
| Package | 1 BOTTLE in 1 CARTON (58624-7012-0) / 24 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2022-04-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |