METRONIDAZOLE 250 MG- metronidazole tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E)

Available from:

Vivimed Labs Limited

INN (International Name):

METRONIDAZOLE

Composition:

METRONIDAZOLE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Product summary:

Metronidazole tablets USP, 250 mg are white, round shaped, biconvex, film coated tablets, debossed with " 28” on one side and plain on the other side. They are supplied as follows: NDC Number     Size 62980-509-01    bottle of 50 62980-509-02    bottle of 100 62980-509-03    bottle of 1000 Metronidazole tablets USP, 500 mg are white, capsule shaped, film coated tablets, debossed with " 29” on one side and plain on the other side. They are supplied as follows: NDC Number     Size 62980-510-01    bottle of 50 62980-510-02    bottle of 500 62980-510-03    bottle of 1000 Storage and Stability: Store below 77°F (25°C) and protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METRONIDAZOLE 250 MG- METRONIDAZOLE TABLET, FILM COATED
VIVIMED LABS LIMITED
----------
METRONIDAZOLE TABLETS, USP
RX ONLY
HOW SUPPLIED
Metronidazole tablets USP, 250 mg are white, round shaped, biconvex,
film coated tablets, debossed
with "
28” on one side and plain on the other side.
They are supplied as follows:
NDC NUMBER SIZE
62980-509-01 bottle of 50
62980-509-02 bottle of 100
62980-509-03 bottle of 1000
Metronidazole tablets USP, 500 mg are white, capsule shaped, film
coated tablets, debossed with "
29” on one side and plain on the other side.
They are supplied as follows:
NDC NUMBER SIZE
62980-510-01 bottle of 50
62980-510-02 bottle of 500
62980-510-03 bottle of 1000
STORAGE AND STABILITY: Store below 77°F (25°C) and protect from
light.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 62980-509-01
METRONIDAZOLE TABLETS, USP
250 MG
50 film coated tablets
RX ONLY
Vivimed
NDC 62980-509-02
METRONIDAZOLE TABLETS, USP
250 MG
100 film coated tablets
RX ONLY
Vivimed
Vivimed
NDC 62980-509-03
METRONIDAZOLE TABLETS, USP
250 MG
1000 film coated tablets
RX ONLY
Vivimed
METRONIDAZOLE 250 MG
metronidazole tablet, film coated
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:6 29 8 0 -50 9
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
METRO NIDAZO LE (UNII: 140 QMO216 E) (METRONIDAZOLE - UNII:140 QMO216
E)
METRONIDAZOLE
250 mg
INACTIVE INGREDIENTS
Vivimed Labs Limited
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)
CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)
HYDRO XYPRO PYL CELLULO SE ( TYPE E) (UNII: 6 6 O7AQV0 RT)
SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)
SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)
STEARIC ACID (UNII: 4ELV7Z6 5AP)
HYPRO MELLO SE 2 9 10 ( 15 MPA.S) (UNII: 36 SFW2JZ0 W)
HYDRO XYPRO PYL CELLULO SE ( TYPE L) (UNII: UKE75GEA7F)
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)
ETHYLCELLULO SE ( 10 MPA.S) (UNII: 3DYK7UYZ6 2)
SHELLAC (UNII: 46 N10 7B71O)
DIACETYLATED MO N