NDC 43063-428

Metformin Hydrochloride

Metformin Hydrochloride

Metformin Hydrochloride is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, In. The primary component is Metformin Hydro.

• Product ID: 43063-428_825a3b40-2102-13e4-e053-2991aa0ab38e
• NDC: 43063-428
• Product Type: Human Prescription Drug
• Proprietary Name: Metformin Hydrochloride
• Generic Name: Metformin Hydrochloride
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2009-12-02
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078596
• Labeler Name: PD-Rx Pharmaceuticals, In
• Substance Name: METFORMIN HYDRO
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Biguanide [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 43063-428-90

90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-428-90)

• Marketing Start Date: 2013-01-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43063-428-30 [43063042830]

Metformin Hydrochloride TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA078596
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-03-22
• Marketing End Date: 2019-11-04

NDC 43063-428-60 [43063042860]

Metformin Hydrochloride TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA078596
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-10-30
• Marketing End Date: 2019-11-04

NDC 43063-428-94 [43063042894]

Metformin Hydrochloride TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA078596
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-01-31
• Marketing End Date: 2019-11-04

NDC 43063-428-90 [43063042890]

Metformin Hydrochloride TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA078596
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-01-31
• Marketing End Date: 2019-11-04

NDC 43063-428-93 [43063042893]

Metformin Hydrochloride TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA078596
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-01-31
• Marketing End Date: 2019-11-04

NDC 43063-428-98 [43063042898]

Metformin Hydrochloride TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA078596
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-08-16
• Marketing End Date: 2019-11-04

Drug Details

Active Ingredients

Ingredient	Strength
METFORMIN HYDROCHLORIDE	500 mg/1

OpenFDA Data

• SPL SET ID: 50cfa86b-055a-4fb7-a884-3661e0a26c61
• Manufacturer:
  • PD-Rx Pharmaceuticals, Inc.
• UNII:
  • 786Z46389E
• RxNorm Concept Unique ID - RxCUI:
  • 860975
• UPC Code:
  • 0343063428900

Pharmacological Class

• Biguanide [EPC]
• Biguanides [CS]

NDC Crossover Matching brand name "Metformin Hydrochloride" or generic name "Metformin Hydrochloride"

NDC	Brand Name	Generic Name
0093-1048	Metformin Hydrochloride	Metformin Hydrochloride
0093-1049	Metformin Hydrochloride	Metformin Hydrochloride
0093-7212	Metformin Hydrochloride	Metformin Hydrochloride
0093-7214	Metformin Hydrochloride	Metformin Hydrochloride
0093-7267	Metformin Hydrochloride	Metformin Hydrochloride
0179-1979	Metformin Hydrochloride	Metformin Hydrochloride
0185-4416	metformin hydrochloride	metformin hydrochloride
0378-6001	Metformin Hydrochloride	metformin
0378-6002	Metformin Hydrochloride	metformin
0378-7185	Metformin Hydrochloride	metformin hydrochloride
0378-7186	Metformin Hydrochloride	metformin hydrochloride
0378-7187	Metformin Hydrochloride	metformin hydrochloride
0440-5739	Metformin Hydrochloride	Metformin Hydrochloride
0440-5745	Metformin Hydrochloride	Metformin Hydrochloride
0440-5746	Metformin Hydrochloride	Metformin Hydrochloride
0591-2411	Metformin Hydrochloride	Metformin Hydrochloride
0591-2412	Metformin Hydrochloride	Metformin Hydrochloride
0591-2719	Metformin Hydrochloride	Metformin Hydrochloride
0591-2720	Metformin Hydrochloride	Metformin Hydrochloride
0615-5583	Metformin Hydrochloride	Metformin Hydrochloride
0615-7626	Metformin Hydrochloride	Metformin Hydrochloride
0615-7627	Metformin Hydrochloride	Metformin Hydrochloride
0615-7628	Metformin Hydrochloride	Metformin Hydrochloride
0615-7661	Metformin Hydrochloride	Metformin Hydrochloride
0615-7662	Metformin Hydrochloride	Metformin Hydrochloride
0615-7663	Metformin Hydrochloride	Metformin Hydrochloride
0615-7847	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE
0615-7982	Metformin Hydrochloride	Metformin Hydrochloride
67877-217	Metformin Hydrochloride	Metformin Hydrochloride
67877-221	Metformin Hydrochloride	Metformin Hydrochloride
67877-218	Metformin Hydrochloride	Metformin Hydrochloride
67877-159	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE
67877-414	Metformin Hydrochloride	Metformin Hydrochloride
67877-413	Metformin Hydrochloride	Metformin Hydrochloride
68071-1781	Metformin hydrochloride	Metformin hydrochloride
68071-1419	Metformin hydrochloride	Metformin hydrochloride
68071-1815	Metformin hydrochloride	Metformin hydrochloride
68071-3117	Metformin hydrochloride	Metformin hydrochloride
68071-3200	Metformin hydrochloride	Metformin hydrochloride
68071-1774	Metformin hydrochloride	Metformin hydrochloride
68071-3226	Metformin Hydrochloride	Metformin Hydrochloride
68071-1927	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE
68071-3370	METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE
68071-3126	Metformin hydrochloride	Metformin hydrochloride
68071-3212	Metformin Hydrochloride	Metformin Hydrochloride
68071-4153	Metformin Hydrochloride	Metformin Hydrochloride
68071-4525	Metformin hydrochloride	Metformin hydrochloride
68071-4560	Metformin hydrochloride	Metformin hydrochloride
68071-4605	Metformin hydrochloride	Metformin hydrochloride
68071-4270	Metformin Hydrochloride	Metformin Hydrochloride