FDA.reportPublic FDA data

EXALGO

Product NDC
23635-408
11-digit product format
236350408
Labeler code
23635
Product ID
23635-408_0cc967c3-2f93-438b-a25c-0a4bbaf4f313
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydromorphone Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
SpecGx LLC
Application
NDA021217
Marketing category
NDA
Marketing start
2010-03-01
Marketing end
2020-12-31
Substance
HYDROMORPHONE HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c92985da-a658-b186-e763-2287eda87a86Product name320250221
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
96c475b3-58c7-b955-d715-0111804a3e50Product name520210512
1dd54659-b775-4fa8-a858-7f0e521fbadcProduct name420200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23635-408-01EA - Each23635-408b9298447-94e8-487c-8765-b3cc6d38b80912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROMORPHONE HYDROCHLORIDEACTIVE INGREDIENTL960UP2KRWEXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [STAT RX USA LLC]1
HYDROMORPHONE HYDROCHLORIDEACTIVE INGREDIENTL960UP2KRWEXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
HYDROMORPHONEACTIVE MOIETYQ812464R06EXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
HYDROMORPHONEACTIVE MOIETYQ812464R06EXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [STAT RX USA LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKEXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KEXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [STAT RX USA LLC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KEXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6EXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE ACETATEINACTIVE INGREDIENT3J2P07GVB6EXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [STAT RX USA LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675EXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [STAT RX USA LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675EXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTEXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357EXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [STAT RX USA LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357EXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4EXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [STAT RX USA LLC]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4EXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XEXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XEXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE, ANHYDROUSINACTIVE INGREDIENT3SY5LH9PMKEXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [STAT RX USA LLC]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AEXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [STAT RX USA LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EEXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [STAT RX USA LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EEXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XEXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [STAT RX USA LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XEXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673EXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673EXALGO (HYDROMORPHONE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [STAT RX USA LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
902738Exalgo 16 MG 24HR Extended Release Oral TabletPSN0dedd480-dc5c-499c-8763-6044b9bd4a6b1
902743Exalgo 8 MG 24HR Extended Release Oral TabletPSNf26ababe-f6f0-443e-8d91-4d2a174675bc1
902743Exalgo 8 MG 24HR Extended Release Oral TabletPSN0dedd480-dc5c-499c-8763-6044b9bd4a6b1
902736HYDROmorphone HCl 16 MG 24HR Extended Release Oral TabletPSN0dedd480-dc5c-499c-8763-6044b9bd4a6b1
902741HYDROmorphone HCl 8 MG 24HR Extended Release Oral TabletPSNf26ababe-f6f0-443e-8d91-4d2a174675bc1
902741HYDROmorphone HCl 8 MG 24HR Extended Release Oral TabletPSN0dedd480-dc5c-499c-8763-6044b9bd4a6b1
90273824 HR hydromorphone hydrochloride 16 MG Extended Release Oral Tablet [Exalgo]SBD0dedd480-dc5c-499c-8763-6044b9bd4a6b1
90274324 HR hydromorphone hydrochloride 8 MG Extended Release Oral Tablet [Exalgo]SBDf26ababe-f6f0-443e-8d91-4d2a174675bc1
90274324 HR hydromorphone hydrochloride 8 MG Extended Release Oral Tablet [Exalgo]SBD0dedd480-dc5c-499c-8763-6044b9bd4a6b1
90273624 HR hydromorphone hydrochloride 16 MG Extended Release Oral TabletSCD0dedd480-dc5c-499c-8763-6044b9bd4a6b1
90274124 HR hydromorphone hydrochloride 8 MG Extended Release Oral TabletSCD0dedd480-dc5c-499c-8763-6044b9bd4a6b1
90274124 HR hydromorphone hydrochloride 8 MG Extended Release Oral TabletSCDf26ababe-f6f0-443e-8d91-4d2a174675bc1
90273824 HR Exalgo 16 MG Extended Release Oral TabletSY0dedd480-dc5c-499c-8763-6044b9bd4a6b1
90274324 HR Exalgo 8 MG Extended Release Oral TabletSY0dedd480-dc5c-499c-8763-6044b9bd4a6b1
90274324 HR Exalgo 8 MG Extended Release Oral TabletSYf26ababe-f6f0-443e-8d91-4d2a174675bc1
902738Exalgo 16 MG 24 HR Extended Release Oral TabletSY0dedd480-dc5c-499c-8763-6044b9bd4a6b1
902743Exalgo 8 MG 24 HR Extended Release Oral TabletSY0dedd480-dc5c-499c-8763-6044b9bd4a6b1
902743Exalgo 8 MG 24 HR Extended Release Oral TabletSYf26ababe-f6f0-443e-8d91-4d2a174675bc1
902736hydromorphone hydrochloride 16 MG 24 HR Extended Release Oral TabletSY0dedd480-dc5c-499c-8763-6044b9bd4a6b1
902741hydromorphone hydrochloride 8 MG 24 HR Extended Release Oral TabletSY0dedd480-dc5c-499c-8763-6044b9bd4a6b1
902741hydromorphone hydrochloride 8 MG 24 HR Extended Release Oral TabletSYf26ababe-f6f0-443e-8d91-4d2a174675bc1