NDC 16110-075

Monodox

Doxycycline

Monodox is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Aqua Pharmaceuticals, Llc. The primary component is Doxycycline.

• Product ID: 16110-075_a6d054f6-c27d-4641-ae0e-a6f59a196f54
• NDC: 16110-075
• Product Type: Human Prescription Drug
• Proprietary Name: Monodox
• Generic Name: Doxycycline
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2007-01-31
• Marketing Category: NDA / NDA
• Application Number: NDA050641
• Labeler Name: Aqua Pharmaceuticals, LLC
• Substance Name: DOXYCYCLINE
• Active Ingredient Strength: 75 mg/1
• Pharm Classes: Tetracycline-class Drug [EPC],Tetracyclines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 16110-075-01

100 CAPSULE in 1 BOTTLE (16110-075-01)

• Marketing Start Date: 2007-01-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16110-075-01 [16110007501]

Monodox CAPSULE

• Marketing Category: NDA
• Application Number: NDA050641
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-01-31

Drug Details

Active Ingredients

Ingredient	Strength
DOXYCYCLINE	75 mg/1

OpenFDA Data

• SPL SET ID: a65325a7-ae0a-4704-99c4-a3a2e4e1dcf2
• Manufacturer:
  • Aqua Pharmaceuticals, LLC
• UNII:
  • N12000U13O
• RxNorm Concept Unique ID - RxCUI:
  • 205621
  • 1649401
  • 700408
  • 205619
  • 700410
  • 1649990
• PHarm Class EPC:
  • Tetracycline-class Drug [EPC]
• UPC Code:
  • 0316110259048
  • 0316110075013
  • 0316110260068
• NUI Code:
  • N0000007948
  • N0000175882

Pharmacological Class

• Tetracycline-class Drug [EPC]
• Tetracyclines [CS]
• Tetracycline-class Drug [EPC]
• Tetracyclines [CS]

NDC Crossover Matching brand name "Monodox" or generic name "Doxycycline"

NDC	Brand Name	Generic Name
16110-259	Monodox	Monodox
16110-075	Monodox	Monodox
16110-260	Monodox	Monodox
0115-1327	Doxycycline	Doxycycline
0143-9381	Doxycycline	Doxycycline
0179-0129	Doxycycline	Doxycycline
0378-5475	Doxycycline	doxycycline
0378-6021	Doxycycline	Doxycycline
0378-6022	Doxycycline	Doxycycline
0378-6023	Doxycycline	Doxycycline
0378-6124	Doxycycline	Doxycycline
0404-9855	DOXYCYCLINE	doxycycline
0527-1335	Doxycycline	Doxycycline
0527-1338	Doxycycline	Doxycycline
0527-1535	Doxycycline	Doxycycline
0527-1537	Doxycycline	Doxycycline
0378-0145	doxycycline hyclate	doxycycline
0378-0148	doxycycline hyclate	doxycycline
0378-0167	doxycycline hyclate	doxycycline
0299-3822	ORACEA	DOXYCYCLINE
0069-0970	Vibramycin Monohydrate	doxycycline