NDC 36800-050

Topcare Ibuprofen PM

Diphenhydramine Citrate And Ibuprofen

Topcare Ibuprofen PM is a Oral Tablet, Film Coated in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Diphenhydramine Citrate; Ibuprofen.

• Product ID: 36800-050_2c0332af-100e-4a39-9c86-63b9626708ee
• NDC: 36800-050
• Product Type: Human Otc Drug
• Proprietary Name: Topcare Ibuprofen PM
• Generic Name: Diphenhydramine Citrate And Ibuprofen
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2009-02-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA079113
• Labeler Name: Topco Associates LLC
• Substance Name: DIPHENHYDRAMINE CITRATE; IBUPROFEN
• Active Ingredient Strength: 38 mg/1; mg/1
• Pharm Classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 36800-050-27

1 BOTTLE in 1 CARTON (36800-050-27) > 80 TABLET, FILM COATED in 1 BOTTLE

• Marketing Start Date: 2009-02-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 36800-050-60 [36800005060]

Topcare Ibuprofen PM TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA079113
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-02-19

NDC 36800-050-58 [36800005058]

Topcare Ibuprofen PM TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA079113
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-02-18

NDC 36800-050-27 [36800005027]

Topcare Ibuprofen PM TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA079113
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-02-24

Drug Details

Active Ingredients

Ingredient	Strength
DIPHENHYDRAMINE CITRATE	38 mg/1

OpenFDA Data

• SPL SET ID: 1435e627-144e-4dc8-9ad6-58d91cbd9094
• Manufacturer:
  • Topco Associates LLC
• UNII:
  • 4OD433S209
  • WK2XYI10QM
• RxNorm Concept Unique ID - RxCUI:
  • 895664
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
• NUI Code:
  • N0000000160
  • N0000175722
  • N0000175721

Medicade Reported Pricing

36800005060 IBUPROFEN PM CAPLET

Pricing Unit: EA | Drug Type:

36800005058 IBUPROFEN PM CAPLET

Pricing Unit: EA | Drug Type:

36800005027 IBUPROFEN PM CAPLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Topcare Ibuprofen PM" or generic name "Diphenhydramine Citrate And Ibuprofen"

NDC	Brand Name	Generic Name
36800-050	Topcare Ibuprofen PM	diphenhydramine citrate and ibuprofen
0573-0164	ADVIL PM	diphenhydramine citrate and ibuprofen
41520-050	Care One Ibuprofen PM	diphenhydramine citrate and ibuprofen
55910-050	dg health Ibuprofen pm	diphenhydramine citrate and ibuprofen
30142-050	ibuprofen pm	diphenhydramine citrate and ibuprofen
59779-050	ibuprofen pm	diphenhydramine citrate and ibuprofen
49348-873	sunmark ibuprofen pm	diphenhydramine citrate and ibuprofen
11673-050	up and up ibuprofen pm	diphenhydramine citrate and ibuprofen