Tramadol Hydrochloride by Galephar Pharmaceutical Research Inc.

Tramadol Hydrochloride by

Drug Labeling and Warnings

Tramadol Hydrochloride by is a Other medication manufactured, distributed, or labeled by Galephar Pharmaceutical Research Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TRAMADOL HYDROCHLORIDE  EXTENDED RELEASE - tramadol hydrochloride capsule, extended release 
Galephar Pharmaceutical Research Inc.

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Principal Display Panel - Drum Label

GALEPHAR P.R. Inc.

NDC: 66277-252-04

GI-252 Tramadol ER 100 mg

(Tramadol Capsules)

Lot # XXXXX

Caution: For further process only

Exp. Date MMM YYYY

Maintain between 15°C 30°C (59°F 86°F)

Gross: Net: Container: of

Lock ID: By/on: /

Km 14.7 #100 Juncos Industrial Park

Juncos, Puerto Rico 00777-3878

Phone: (787) 713-0340 Fax: (787) 713-0344

Principal Display Panel - Pail label

NDC#: 66277-252-05

Tramadol HCl ER

100 mg CAPSULES

Container of up to 10,000 Capsules

Lot:

Expiration Date:

Gross: kg

Road 198, Km. 14.2 Juncos Industrial Park

Juncos, PR 00777

Phone: (787) 389-0340

Principal Display Panel - Box Label

Manufacturer:

GALEPHAR PHARMA RESEARCH INC

Juncos Industrial Park Road 198 Km 14.2

Juncos, Puerto Rico 00777

NDC: 66277-252-06

ULTRAGESIC 100 MG

5 CAPSULES

SHIPPERS OF 12 BOTTLES

QTY: 12 Serial#: 000000

LOT#: LLLLLLL

EXP. DATE: MMYYYY

STORE AT 15°C 30°C (59°F 86°F)

Country of Origin: Puerto Rico

P.O. Number: XXXX

GK-384

Principal Display Panel - Drum Label

GALEPHAR P.R. Inc.

NDC: 66277-322-01

GI-322 Tramadol ER 150 mg

(Tramadol Capsules)

Lot # XXXXX

Caution: For further process only

Exp. Date MMM YYYY

Maintain between 15°C 30°C (59°F 86°F)

Gross: Net: Container: of

Lock ID: By/on: /

km 14.7 #100 Juncos Industrial Park

Juncos, Puerto Rico 00777-3878

Phone: (787) 713-0340 Fax: (787) 713-0344

Principal Display Panel - Pail label

NDC#: 66277-322-02

Tramadol HCl ER

150 mg CAPSULES

Container of up to 10,000 Capsules

Lot:

Expiration Date:

Gross: kg

Road 198, Km. 14.2 Juncos Industrial Park

Juncos, PR 00777

Phone: (787) 389-0340

Principal Display Panel - Box Label

Manufacturer:

GALEPHAR PHARMA RESEARCH INC

Juncos Industrial Park Road 198 Km 14.2

Juncos, Puerto Rico 00777

NDC: 66277-322-04

ULTRAGESIC 150 MG

5 CAPSULES

SHIPPERS OF 12 BOTTLES

QTY: 12 Serial#: 000000

LOT#: LLLLLLL

EXP. DATE: MMYYYY

STORE AT 15°C 30°C (59°F 86°F)

Country of Origin: Puerto Rico

P.O. Number: XXXX

GK-385

Principal Display Panel - Drum Label

GALEPHAR P.R. Inc.

NDC: 66277-253-04

GI-253 Tramadol ER 200 mg

(Tramadol Capsules)

Lot # XXXXX

Caution: For further process only

Exp. Date MMM YYYY

Maintain between 15°C 30°C (59°F 86°F)

Gross: Net: Container: of

Lock ID: By/on: /

km 14.7 #100 Juncos Industrial Park

Juncos, Puerto Rico 00777-3878

Phone: (787) 713-0340 Fax: (787) 713-0344

Principal Display Panel - Pail label

NDC#: 66277-253-05

Tramadol HCl ER

200 mg CAPSULES

Container of up to 10,000 Capsules

Lot:

Expiration Date:

Gross: kg

Road 198, Km. 14.2 Juncos Industrial Park

Juncos, PR 00777

Phone: (787) 389-0340

Principal Display Panel - Box Label

Manufacturer:

GALEPHAR PHARMA RESEARCH INC

Juncos Industrial Park Road 198 Km 14.2

Juncos, Puerto Rico 00777

NDC: 66277-253-06

ULTRAGESIC 200 MG

5 CAPSULES

SHIPPERS OF 12 BOTTLES

QTY: 12 Serial#: 000000

LOT#: LLLLLLL

EXP. DATE: MMYYYY

STORE AT 15°C 30°C (59°F 86°F)

Country of Origin: Puerto Rico

P.O. Number: XXXX

GK-386

Principal Display Panel - Drum Label

GALEPHAR P.R. Inc.

NDC: 66277-254-04

GI-254 Tramadol ER 300 mg

(Tramadol Capsules)

Lot # XXXXX

Caution: For further process only

Exp. Date MMM YYYY

Maintain between 15°C 30°C (59°F 86°F)

Gross: Net: Container: of

Lock ID: By/on: /

km 14.7 #100 Juncos Industrial Park

Juncos, Puerto Rico 00777-3878

Phone: (787) 713-0340 Fax: (787) 713-0344

Principal Display Panel - Pail label

NDC#: 66277-254-05

Tramadol HCl ER

300 mg CAPSULES

Container of up to 10,000 Capsules

Lot:

Expiration Date:

Gross: kg

Road 198, Km. 14.2 Juncos Industrial Park

Juncos, PR 00777

Phone: (787) 389-0340

TRAMADOL HYDROCHLORIDE   EXTENDED RELEASE
tramadol hydrochloride capsule, extended release

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 66277-252
Route of Administration	NOT APPLICABLE	DEA Schedule	CIV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)	TRAMADOL HYDROCHLORIDE	100 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SHELLAC (UNII: 46N107B71O)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SUCROSE STEARATE (UNII: 274KW0O50M)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
TALC (UNII: 7SEV7J4R1U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) (UNII: P2OM2Q86BI)

Product Characteristics
Color	white (white)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	19mm
Flavor		Imprint Code	G;252;100
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66277-252-04	77640 in 1 DRUM	08/31/2011
2	NDC: 66277-252-05	10000 in 1 PAIL	08/31/2011
3	NDC: 66277-252-06	12 in 1 BOX	08/31/2011
3		5 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		08/31/2011

TRAMADOL HYDROCHLORIDE   EXTENDED RELEASE
tramadol hydrochloride capsule, extended release

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 66277-322
Route of Administration	NOT APPLICABLE	DEA Schedule	CIV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)	TRAMADOL HYDROCHLORIDE	150 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SUCROSE STEARATE (UNII: 274KW0O50M)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
TALC (UNII: 7SEV7J4R1U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) (UNII: P2OM2Q86BI)

Product Characteristics
Color	white (white)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	19mm
Flavor		Imprint Code	G;322;150
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66277-322-01	57737 in 1 DRUM	08/31/2011
2	NDC: 66277-322-02	10000 in 1 PAIL	08/31/2011
3	NDC: 66277-322-04	12 in 1 BOX	08/31/2011
3		5 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		08/31/2011

TRAMADOL HYDROCHLORIDE   EXTENDED RELEASE
tramadol hydrochloride capsule, extended release

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 66277-253
Route of Administration	NOT APPLICABLE	DEA Schedule	CIV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)	TRAMADOL HYDROCHLORIDE	200 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SHELLAC (UNII: 46N107B71O)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SUCROSE STEARATE (UNII: 274KW0O50M)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
TALC (UNII: 7SEV7J4R1U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) (UNII: P2OM2Q86BI)

Product Characteristics
Color	white (white)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	22mm
Flavor		Imprint Code	G;253;200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66277-253-04	58594 in 1 DRUM	08/31/2011
2	NDC: 66277-253-05	10000 in 1 PAIL	08/31/2011
3	NDC: 66277-253-06	12 in 1 BOX	08/31/2011
3		5 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		08/31/2011

TRAMADOL HYDROCHLORIDE   EXTENDED RELEASE
tramadol hydrochloride capsule, extended release

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 66277-254
Route of Administration	NOT APPLICABLE	DEA Schedule	CIV

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRAMADOL HYDROCHLORIDE (UNII: 9N7R477WCK) (TRAMADOL - UNII:39J1LGJ30J)	TRAMADOL HYDROCHLORIDE	300 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SHELLAC (UNII: 46N107B71O)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SUCROSE STEARATE (UNII: 274KW0O50M)
POVIDONE K30 (UNII: U725QWY32X)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
TALC (UNII: 7SEV7J4R1U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW) (UNII: P2OM2Q86BI)

Product Characteristics
Color	white (white)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	23mm
Flavor		Imprint Code	G;254;300
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66277-254-04	39370 in 1 DRUM	08/31/2011
2	NDC: 66277-254-05	10000 in 1 PAIL	08/31/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		08/31/2011

Labeler - Galephar Pharmaceutical Research Inc. (003551624)

Establishment
Name	Address	ID/FEI	Business Operations
Galephar Pharmaceutical Research Inc.		003551624	MANUFACTURE(66277-252, 66277-322, 66277-253, 66277-254) , ANALYSIS(66277-252, 66277-322, 66277-253, 66277-254) , PACK(66277-252, 66277-322, 66277-253, 66277-254)

Revised: 1/2020

Document Id: fb33d099-7eea-411c-bd8a-dbed7f4a6c68

53409-9

Set id: c4f67ec5-6830-48cd-b550-520c298831e7

Version: 2

Effective Time: 20200122