Ibuprofen Pm Capsule, Liquid Filled
NDC Package 36800-237-15
Package Information
Ibuprofen Pm (ibuprofen, diphenhydramine hcl) capsules is ■ do not take more than directed■ adults and children 12 years and over: take 2 capsules at bedtime■ do not take more than 2 capsules in 24 hours. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Top Care (topco Associates Llc), this product is identified by NDC 36800-237 and is authorized under FDA application ANDA090397.
Identification & Billing
- RxCUI: 901814 - ibuprofen 200 MG / diphenhydrAMINE HCl 25 MG Oral Capsule
- RxCUI: 901814 - diphenhydramine hydrochloride 25 MG / ibuprofen 200 MG Oral Capsule
Clinical Specifications
- Anti-Inflammatory Agents, Non-Steroidal - [CS]
- Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
- Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
- Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 36800 - Top Care (topco Associates Llc)
- 36800-237 - Ibuprofen Pm
- 36800-237-15 - 1 BOTTLE, PLASTIC in 1 CARTON / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
- 36800-237 - Ibuprofen Pm
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 36800-237-15 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 40 capsule, liquid filled in 1 bottle, plastic of Ibuprofen Pm, a human over the counter drug labeled by Top Care (topco Associates Llc). This capsule, liquid filled is formulated for oral use and contains diphenhydramine hydrochloride; ibuprofen as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Top Care (topco Associates Llc) on October 15, 2021. The current certification is valid through December 31, 2026.
How is this Top Care (topco Associates Llc) product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800023715. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.