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Form Approved: OMB No. 0910-0045. Expiration Date: December 31, 2007. See OMB Statement on Reverse.
NAME AND ADDRESS OF FIRM
LABELING REVISON
DEPARTMENT OF HEALTH AND HUMANS SERVICES
CHANGE OF:
FOOD AND DRUG ADMINISTRATION
RTE OF ADMIN
DRUG PRODUCT LISTING
INDICATION
NAME / DOSE / STR / INGR
(In accordance with Public Law 92-387)
FOR
FDA
CONTROL NO.
1
5
RECORD ID
6
11
12
15
USE
OTHER (Specify)
NATIONAL DRUG CODE
SEC
16
17
S U
18
19
PRODUCT TRADE NAME OR CATALOG NAME
LABELER
20
83
84
PRODUCT
89
90
93
99 100
102
105 106 107
143 144
147 148
151 152
111
OTH
PT
155 156 157-158
112
SEC
S
U
16
18
19
20
17
PKG
CODE
21
22
116
PRODUCT DISCONTINUED
PROF
USE
SCHED
OTHER (Specify)
BNDD
YR
ROUTES OF ADMINISTRATION
1
2
3
DOSAGE
FORM
141
DA
PRODUCT TYPE
OTHER (Specify)
SMPL
94
MO
TYPES OF BUSINESS
TYPE
RPRT
REPORT DATE
FDA
APPLICATION NO.
LEGAL
STATUS
0 1
117 118 119 120 121
WHOLE NUMBERS
125
126
PACKAGE SIZE
23
BASIS OF CONCENTRATION
OTHER (Specify)
133 134
48
72
0 3
159
161
MOST RECENT
MARKETING DATE
MO
YEAR
164 165
167
DISCONTINUED
DATE
MO
YEAR
170 171
173
176
0 3
0 3
S U
TYPE
0 3
SEC
16
18
20
17
19
PT
21
22
137 138
140
PACKAGE TYPE
47
0 3
INITIAL
MARKETING DATE
MO
YEAR
UNIT
DECIMAL
44
AMOUNT
WHOLE NUMBER
FDA USE ONLY
INGREDIENT NO.
ESTABLISHED NAME OF PRODUCT AND / OR INGREDIENT(S) OR BIOLOGIC PROPER NAME, TEST OBJECTIVE / EQUIPMENT / REAGENT NAME, ETC.
100 23
28
29
35
NOTICE: This report
is required by law
(21 C.F.R. 207.20).
Failure to report can
result in imprisonment
for not more than one
year or a fine of not
more than $1,000, or
both (FDA&C Act,
Section 303).
UNIT
DECIMAL
37
40
41
43
0 5
0 5
0 5
0 5
0 5
0 5
0 5
0 5
0 5
0 5
SEC
S U
16
18
17
19
SITE OR FIRM ESTABLISHMENT
REGISTRATION NUMBER
20
ACTUAL MANUFACTURING SITE OF THE ABOVE DRUG PRODUCT
29
30
FOREIGN COUNTRY
STATE
68
69
70
71
SHORT NAME
NDC LABELER CODE
80
81
86
87
101
0 7
0 7
0 7
FORM FDA 2657 (8 /07)
PREVIOUS EDITION IS OBSOLETE.
PSC Graphics: (301) 443-1090
EF
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Public reporting burden for this collection of information is estimated to average 30 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing
this burden to:
Food and Drug Administration
CDER/Drug Registration and Listing (HFD-337)
5600 Fishers Lane
Rockville, MD 20857
An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number.
FOLD HERE
FOLD HERE
Please fold form where indicated, place in a window
envelope, and return to address indicated.
RETURN THIS FORM TO:
FOOD AND DRUG ADMINISTRATION
CDER/DRUG REGISTRATION AND LISTING (HFD-337)
5600 FISHERS LANE
ROCKVILLE, MD 20857
Food and Drug Administration
CDER/Drug Registration and Listing (HFD-337)
5600 Fishers Lane
Rockville, MD 20857
FOLD HERE
FOLD HERE
If using Federal Express, DHL or any special carrier to return this form, please use the
following address:
(Please refer to the Drug Registration and Listing Booklet.)
When completing this form, please refer to the Drug Registration and Listing Instruction Booklet for assistance.
PLEASE PRINT IN ENGLISH USING BLACK INK.
FOLD HERE
FOLD HERE
FORM FDA 2657 (8/07) (BACK)
| File Type | application/pdf |
| File Title | untitled |
| File Modified | 2007-12-03 |
| File Created | 2007-09-06 |