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NDC 27854-0301-01 SEDALMEX 500; 65 mg/1; mg/1 Details
SEDALMEX 500; 65 mg/1; mg/1
SEDALMEX is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Belmora LLC. The primary component is ACETAMINOPHEN; CAFFEINE.
Product Information
| NDC | 27854-0301 |
|---|---|
| Product ID | 27854-301_de59f666-f6ed-4ba2-aca2-45df8b877d09 |
| 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 | SEDALMEX |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Caffeine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 500; 65 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; CAFFEINE |
| Labeler Name | Belmora LLC |
| Pharmaceutical Class | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M013 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 27854-0301-01 (27854030101)
| NDC Package Code | 27854-301-01 |
|---|---|
| Billing NDC | 27854030101 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (27854-301-01) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2019-08-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |