novonordisk.comOzempic
semaglutide
NOVO NORDISK INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2244771 | 2244771 | NOVO NORDISK INC. | 1 | Y | 2026-01-01 | 800 Scudders Mill Rd Plainsboro NJ US 08536 |
| 9681821 | 3003131673 | NOVO NORDISK A/S | 1 | N | 2026-01-01 | BRENNUM PARK HILLEROED Hovedstaden DK DK-3400 |
| 3005186124 | 3005186124 | Novo Nordisk (China) Pharmaceuticals, Co. Ltd. | 1 | N | 2026-01-01 | 99 Nanhai Road TEDA Tianjin CN 300457 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00301691854591 | NovoPen Echo® - NovoPen Echo® is a re-usable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart injection], Fiasp® 100 units/mL (U-100) [insulin aspart injection], and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments. | +18007276500 | nnicustomercare@novonordisk.com |
| 00301691855505 | NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection. | +18007276500 | nnicustomercare@novonordisk.com |
| 00301691855918 | NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection. | +18007276500 | nnicustomercare@novonordisk.com |
| 00301691856502 | NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection. | +18007276500 | nnicustomercare@novonordisk.com |
| 00301691856519 | NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin, GLP-1 analogs, and somatropin. | +18007276500 | nnicustomercare@novonordisk.com |
| 00301691858506 | NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection. | +18007276500 | nnicustomercare@novonordisk.com |
| 00301691858513 | NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection. | +18007276500 | nnicustomercare@novonordisk.com |
| 00301697200064 | Administration Set - Administration set for infusion containing 2 alcohol swabs, 1 infusion set, 2 gauze pads, and 2 bandages. | +18007276500 | nnicustomercare@novonordisk.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 16570 | 1698140132 | K231255 | NovoFine® Plus | FMI | 2023-08-25 |
| 16571 | 1423395103 | K210258 | NovoFine | FMI | 2021-06-23 |
| 16570 | 1423395103 | K210258 | NovoFine | FMI | 2021-06-23 |
| 16571 | 1382197461 | K202005 | NovoFine Plus 32G Tip x 4 mm | FMI | 2020-12-19 |
| 16570 | 1382197461 | K202005 | NovoFine Plus 32G Tip x 4 mm | FMI | 2020-12-19 |
| 186103 | 2008167522 | K182387 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | FMF | 2018-12-17 |
| 16571 | 2008167522 | K182387 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | FMF | 2018-12-17 |
| 16570 | 2008167522 | K182387 | NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) | FMF | 2018-12-17 |
| 16570 | 1745006875 | K173479 | NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) | FMI | 2018-01-17 |
| 16571 | 1745006875 | K173479 | NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) | FMI | 2018-01-17 |
| 16570 | 1643284362 | K162602 | NovoPen Echo | FMF | 2016-10-18 |
| 186103 | 1643284362 | K162602 | NovoPen Echo | FMF | 2016-10-18 |
| 16571 | 1643284362 | K162602 | NovoPen Echo | FMF | 2016-10-18 |
| 16570 | 1189984943 | K133738 | NOVOFINE PLUS 32G 4 MM | FMI | 2014-05-21 |
| 16571 | 1189984943 | K133738 | NOVOFINE PLUS 32G 4 MM | FMI | 2014-05-21 |
| 16571 | 1051318870 | K093109 | NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') | FMI | 2010-06-18 |
| 16570 | 1051318870 | K093109 | NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') | FMI | 2010-06-18 |
| 16570 | 1016246524 | K090111 | FLEXPEN NEEDLE | FMI | 2010-02-01 |
| 16571 | 1016246524 | K090111 | FLEXPEN NEEDLE | FMI | 2010-02-01 |
| 16570 | 1080572543 | K050106 | NOVOFINE AUTOCOVER 30G X 8MM | FMI | 2005-03-30 |
| 16571 | 1080572543 | K050106 | NOVOFINE AUTOCOVER 30G X 8MM | FMI | 2005-03-30 |
| 16571 | 1012223184 | ||||
| 16570 | 1012223184 | ||||
| 16571 | 1610738297 | ||||
| 16570 | 1610738297 | ||||
| 16571 | 1844645649 | ||||
| 16570 | 1844645649 |
Product Codes Associated With Registrations#
NDC#
Ozempic
semaglutide
Ozempic
semaglutide
Macrilen
Macimorelin acetate
WEGOVY
semaglutide
WEGOVY
semaglutide
WEGOVY
semaglutide
WEGOVY
semaglutide
WEGOVY
semaglutide
OZEMPIC
oral semaglutide
OZEMPIC
oral semaglutide
OZEMPIC
oral semaglutide
Novolin
Human Insulin
Novolin
Human Insulin
Novolin
Human Insulin
Zegalogue
dasiglucagon
Zegalogue
dasiglucagon
Insulin Diluting Medium for NovoLog
water injection
SOGROYA
somapacitan-beco
SOGROYA
somapacitan-beco
SOGROYA
somapacitan-beco
Alhemo
concizumab
Alhemo
concizumab
Alhemo
concizumab
NOVOLOG
insulin aspart
NOVOLOG
insulin aspart
NovoLog Mix 70/30
insulin aspart
NovoLog Mix 70/30
insulin aspart
Tresiba
insulin degludec
Tresiba
insulin degludec
Tresiba
insulin degludec
Saxenda
liraglutide
Xultophy 100/3.6
insulin degludec and liraglutide
Novolin
Human Insulin
Novolin
Human Insulin
Novolin
Human Insulin
Awiqli
Insulin icodec-abae
Awiqli
Insulin icodec-abae
Awiqli
Insulin icodec-abae
Fiasp
insulin aspart injection
PMN#
NovoFine® Plus
Novo Nordisk, Inc.
NovoFine
Novo Nordisk Inc.
NovoFine Plus 32G Tip X 4 Mm
Novo Nordisk Inc.
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
Novo Nordisk Inc.
NovoFine 32G Tip (0.23/0.25) X 6 Mm ETW (extra Thin Wall)
Novo Nordisk Inc.
NovoPen Echo
Novo Nordisk Inc.
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
NOVO NORDISK INC.
NOVOFINE PLUS 32G 4 MM
NOVO NORDISK INC.
NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN
NOVO NORDISK INC.
NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')
NOVO NORDISK INC.
FLEXPEN NEEDLE
NOVO NORDISK INC.
FLEXPEN NEEDLE
NOVO NORDISK INC.
NOVOFINE 32G TIP
NOVO NORDISK INC.
NOVOFINE AUTOCOVER 30G X 8MM
NOVO NORDISK INC.
INNOVO
Novo Nordisk A/S
NOVOPEN 1.5
NOVO NORDISK PHARMACEUTICALS, INC.
NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY DEVICE
NOVO NORDISK PHARMACEUTICALS, INC.
IDEIA(TM) CHLAMYDIA, MODIFICATION
NOVO NORDISK DIAGNOSTICS, LTD.
ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA
NOVO NORDISK DIAGNOSTICS, LTD.
Applications#
GUDID#
Administration Set - Administration set for infusion containing 2 alcohol swabs, 1 infusion set, 2 gauze pads, and 2 bandages.
2017-06-13
NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection.
2017-12-06
NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection.
2017-12-06
NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin, GLP-1 analogs, and somatropin.
2017-12-06
NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection.
2017-12-06
NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection.
2016-09-17
NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection.
2016-09-17
NovoPen Echo® - NovoPen Echo® is a re-usable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart injection], Fiasp® 100 units/mL (U-100) [insulin aspart injection], and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments.
2016-11-23
NovoFine® Autocover® 30G - NovoFine® Autocover® is a sterile, non-toxic, non-pyrogenic, single use injection needle designed and recommended for use with Novo Nordisk® insulin delivery devices.
2016-09-17
NovoFine® 32G Tip - NovoFine® 32G Tip is a sterile disposable needle.
2016-09-17
NovoFine® 32G Tip - NovoFine® 32G Tip is a sterile disposable needle.
2016-09-17
FlexPro® PenMate® - Auto-insertion accessory only for Norditropin® FlexPro® 5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL prefilled pens. Designed and intended for use with Novo Nordisk® disposable needles.
2019-08-08
NovoFine® Autocover® 30G - NovoFine® Autocover® is a sterile, non-toxic, non-pyrogenic, single use injection needle designed and recommended for use with Novo Nordisk® insulin delivery devices.
2016-09-17
NovoFine® 30G - NovoFine® 30G is a sterile, nontoxic, non-pyrogenic, single use injection needle designed and recommended for use with FlexPen® and all other Novo Nordisk® insulin delivery devices.
2016-09-17
NovoPen Echo® - NovoPen Echo® is a re-usable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart injection], Fiasp® 100 units/mL (U-100) [insulin aspart injection], and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments.
2016-11-23
NovoFine® 32G Tip - NovoFine® 32G Tip is a sterile disposable needle.
2016-09-17
NovoFine® 32G Tip - NovoFine® 32G Tip is a sterile disposable needle.
2016-09-17
NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin, GLP-1 analogs, and somatropin.
2017-12-06
NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin, GLP-1 analogs, and somatropin.
2017-12-06
NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin, GLP-1 analogs, and somatropin.
2017-12-06
NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin, GLP-1 analogs, and somatropin.
2017-12-06
NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin, GLP-1 analogs, and somatropin.
2016-09-17
NovoFine® Plus 32G - NovoFine® Plus 32G needles are disposable, single use, sterile needles and intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin, GLP-1 analogs, and somatropin.
2016-09-17
NovoTwist® 32G - NovoTwist® 32G is a single use disposable injection needle intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, and somatropin.
2016-09-17
NovoFine® Autocover® 30G - NovoFine® Autocover® is a sterile, non-toxic, non-pyrogenic, single use injection needle designed and recommended for use with Novo Nordisk® insulin delivery devices.
2016-09-17
NovoFine® Autocover® 30G - NovoFine® Autocover® is a sterile, non-toxic, non-pyrogenic, single use injection needle designed and recommended for use with Novo Nordisk® insulin delivery devices.
2016-09-17
NovoTwist® 32G - NovoTwist® 32G is a single use disposable injection needle intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, and somatropin.
2016-09-17
Administration Set - Administration set for infusion containing 2 alcohol swabs, 1 infusion set, 2 gauze pads, and 2 bandages.
2017-06-13
NovoFine® 30G - NovoFine® 30G is a sterile, nontoxic, non-pyrogenic, single use injection needle designed and recommended for use with FlexPen® and all other Novo Nordisk® insulin delivery devices.
2016-09-17