Hydromorphone Hydrochloride (Page 5 of 5)

SAFETY AND HANDLING INSTRUCTIONS

Hydromorphone hydrochloride tablets pose little risk of direct exposure to healthcare personnel and should be handled and disposed of prudently in accordance with hospital or institutional policy. Significant absorption from dermal exposure is unlikely. Patients and their families should be instructed to flush any hydromorphone hydrochloride tablets that are no longer needed.

Access to abusable drugs such as hydromorphone hydrochloride tablets presents an occupational hazard for addiction in the healthcare industry. Routine procedures for handling controlled substances developed to protect the public may not be adequate to protect healthcare workers. Implementation of more effective accounting procedures and measures to restrict access to drugs of this class (appropriate to the practice setting) may minimize the risk of self-administration by healthcare providers.

HOW SUPPLIED

Hydromorphone hydrochloride tablets, USP , for oral administration, are supplied as follows:

2 mg: Round, flat face, beveled-edge blue tablet, debossed “E” on one side and “2” on the other side.
100 Count Bottle…………………………..NDC 58177-620-04
1000 Count Bottle…………………………NDC 58177-620-09
100 Count Unit Dose Packs……………….NDC 58177-620-11

4 mg: Round, flat face, beveled-edge tan tablet, debossed “E” on one side and “4” on the other side.
100 Count Bottles…………………………NDC 58177-621-04
1000 Count Bottles……………………….NDC 58177-621-09
100 Count Unit Dose Packs………………NDC 58177-621-11

8 mg: Round, flat face, beveled-edge white tablet, debossed “E” on one side and “8” through partial bisect on the other side.
100 Count Bottle…………………………..NDC 58177-449-04
1000 Count Bottle…………………………NDC 58177-449-09
100 Count Unit Dose Packs………………NDC 58177-449-11

STORAGE

Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.] Protect from light.

A Schedule CII Narcotic. DEA Order Form Is Required.

Manufactured by
KV Pharmaceutical Co. for
ETHEX Corporation St. Louis, MO 63044

P4953-1 10/06

HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58177-620
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydromorphone hydrochloride (Hydromorphone) Hydromorphone 2 mg
Inactive Ingredients
Ingredient Name Strength
colloidal silicon dioxide
lactose hydrous
magnesium stearate
microcrystalline cellulose
sodium starch glycolate
FD&C Blue No. 1 aluminum lake
Product Characteristics
Color blue (BLUE) Score no score
Shape ROUND (Round) Size 6mm
Flavor Imprint Code E;2
Contains
Coating false Symbol true
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58177-620-04 100 TABLET (100 TABLET) in 1 BOTTLE None
2 NDC:58177-620-09 1000 TABLET (1000 TABLET) in 1 BOTTLE None
3 NDC:58177-620-11 100 TABLET (100 TABLET) in 1 BOX, UNIT-DOSE None
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58177-621
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydromorphone hydrochloride (Hydromorphone) Hydromorphone 4 mg
Inactive Ingredients
Ingredient Name Strength
colloidal silicon dioxide
lactose hydrous
magnesium stearate
microcrystalline cellulose
sodium starch glycolate
FD&C Blue No. 1 aluminum lake
FD&C Red No. 40 aluminum lake
FD&C Yellow No. 6 aluminum lake
Product Characteristics
Color brown (TAN) Score no score
Shape ROUND (Round) Size 6mm
Flavor Imprint Code E;4
Contains
Coating false Symbol true
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58177-621-04 100 TABLET (100 TABLET) in 1 BOTTLE None
2 NDC:58177-621-09 1000 TABLET (1000 TABLET) in 1 BOTTLE None
3 NDC:58177-621-11 100 TABLET (100 TABLET) in 1 BOX, UNIT-DOSE None
HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58177-449
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydromorphone hydrochloride (Hydromorphone) Hydromorphone 8 mg
Inactive Ingredients
Ingredient Name Strength
colloidal silicon dioxide
lactose hydrous
magnesium stearate
microcrystalline cellulose
sodium starch glycolate
Product Characteristics
Color white (White) Score no score
Shape ROUND (Round) Size 6mm
Flavor Imprint Code E;8
Contains
Coating false Symbol true
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58177-449-04 100 TABLET (100 TABLET) in 1 BOTTLE None
2 NDC:58177-449-09 1000 TABLET (1000 TABLET) in 1 BOTTLE None
3 NDC:58177-449-11 100 TABLET (100 TABLET) in 1 BOX, UNIT-DOSE None
Labeler — ETHEX Corporation

Revised: 01/2007 ETHEX Corporation

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