Form FDA Form 2658 FDA Form 2658 Registered Establishment

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FOR FDA USE

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

REPORTING FIRM

CONTROL NO.

REGISTERED ESTABLISHMENTS’ REPORT OF
PRIVATE LABEL DISTRIBUTORS

1

5

REPORTING FIRM NDC CODE
ESTABLISHMENT
REGISTRATION NO.

NAME (As shown on Form FDA 2656, Line 2, Columns 61-100)
272/27

321 251/79

318

RPRT DATE

NUMBER AND STREET

CITY

101

PRODUCT

LABELER

311 312/20

SITE ADDRESS

LINE

2

Form Approved: OMB No. 0910-0045. Expiration Date: December 31, 2007.

138 139

ZIP CODE

STATE
158 159

161

FOREIGN COUNTRY

MO.

165 166

175

YR.

14/100

MAILING ADDRESS (If different from Line 2)
NUMBER AND STREET

CITY
213 214

176

3

RECORD ID
6

4

11 12

SEC

S U

ZIP CODE

STATE
233 234

236

FOREIGN COUNTRY

240 241

250

TRADE NAME OR ESTABLISHED NAME UNDER WHICH PRODUCT IS MARKETED BY ANOTHER FIRM

15 16 17 18 19 20

83

0 1
NDC CODE
PRODUCT
LABELER
40/84

5

90

FIRM NAME ON LABEL

SHORT NAME

93 46

SEC

60 61

PACKAGE CODE
1

2

100 16 17 21 22 21

3
21

ZIP CODE

4
21

5
21

0 3
RECORD ID
6

6

11 12

SEC

S U

TRADE NAME OR ESTABLISHED NAME UNDER WHICH PRODUCT IS MARKETED BY ANOTHER FIRM

15 16 17 18 19 20

83

0 1
NDC CODE
PRODUCT
LABELER
40/84

7

90

FIRM NAME ON LABEL

SHORT NAME

93 46

SEC

60 61

PACKAGE CODE
1

2

100 16 17 21 22 21

3
21

ZIP CODE

4
21

5
21

0 3
RECORD ID
6

8

11 12

SEC

S U

TRADE NAME OR ESTABLISHED NAME UNDER WHICH PRODUCT IS MARKETED BY ANOTHER FIRM

15 16 17 18 19 20

83

0 1
NDC CODE
PRODUCT
LABELER
40/84

9

90

FIRM NAME ON LABEL

SHORT NAME

93 46

SEC

60 61

PACKAGE CODE
1

2

100 16 17 21 22 21

3
21

ZIP CODE

4
21

5
21

0 3
RECORD ID

10

11 12

6

SEC

S U

TRADE NAME OR ESTABLISHED NAME UNDER WHICH PRODUCT IS MARKETED BY ANOTHER FIRM

15 16 17 18 19 20

83

0 1
NDC CODE
PRODUCT
LABELER

11

40/84

90

FIRM NAME ON LABEL

SHORT NAME

93 46

60 61

SEC

PACKAGE CODE
1

100 16 17 21 22 21

2

3
21

ZIP CODE

4
21

5
21

0 3
FORM FDA 2658 (8/07)
EF

PSC Graphics: (301) 443-1090

PREVIOUS EDITION IS OBSOLETE.

PAGE

OF

PAGES.

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 (FD&C Act, Section 303).

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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.

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Please fold form where indicated, place in a window
envelope, and return to address indicated.

Food and Drug Administration
CDER/Drug Registration and Listing (HFD-337)
5600 Fishers Lane
Rockville, MD 20857

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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 Instruction booklet.)
When completing this form, please refer to the Drug Registration and Listing Instruction Booklet for assistance.
PLEASE PRINT IN ENGLISH USING BLACK INK.

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FORM FDA 2658 (8/07) (BACK)