FDA.reportPublic FDA data

Hydrocodone Polistirex and Chlorpheniramine Polistirex

Product NDC
27808-086
11-digit product format
278080086
Labeler code
27808
Product ID
27808-086_b3ac95d4-bef9-4e32-9822-73b9534c9869
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Polistirex and Chlorpheniramine Polistirex
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Cranbury Pharmaceuticals, LLC
Application
ANDA091632
Marketing category
ANDA
Marketing start
2015-03-06
Substance
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE
Active strength
8; 10 mg/5mL; mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hydrocodone Polistirex and Chlorpheniramine Polistirex
Brand name suffix
extended-release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE8 mg/5mL
HYDROCODONE BITARTRATE10 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV1Q0O9OJ9Z, NO70W886KK
Rxcui1087459

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
53523715-c529-4d52-b9ff-1e5d76636f53Product name220210818
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
31b11e56-5b35-4ab6-a3a8-f0b48973dcedProduct name220200611
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
7855f8e3-562e-4273-8b79-0059c07a71f7Product name120170901
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
a5244f9c-cd67-0e27-d63b-65fd7e584400Product name220170504
b654f2d9-ebeb-451d-96ee-22f583344623Product name120170424
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27808-086-01Hydrocodone Polistirex and Chlorpheniramine Polistirexextended-release115 mL in 1 BOTTLE, UNIT-DOSESUSPENSION, EXTENDED RELEASE11527
27808-086-01Hydrocodone Polistirex and Chlorpheniramine Polistirexextended-release1 in 1 CARTONSUSPENSION, EXTENDED RELEASE127
27808-086-02Hydrocodone Polistirex and Chlorpheniramine Polistirexextended-release473 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE47327
27808-086-03Hydrocodone Polistirex and Chlorpheniramine Polistirexextended-release1 in 1 CARTONSUSPENSION, EXTENDED RELEASE127
27808-086-03Hydrocodone Polistirex and Chlorpheniramine Polistirexextended-release70 mL in 1 BOTTLE, UNIT-DOSESUSPENSION, EXTENDED RELEASE7027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27808-086-01ML - Milliliter27808-086681d3bc3-bcbe-49c2-85b2-78f77b7a7d8d12015-10-02
27808-086-02ML - Milliliter27808-08649eb458c-458e-4780-ab01-938ee74b59ec12015-10-02
27808-086-03ML - Milliliter27808-0868575a272-3124-4ccb-937b-0366b903d6af12019-12-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORPHENIRAMINE MALEATEACTIVE INGREDIENTV1Q0O9OJ9ZHYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]7
HYDROCODONE BITARTRATEACTIVE INGREDIENTNO70W886KKHYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]7
CHLORPHENIRAMINEACTIVE MOIETY3U6IO1965UHYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]7
HYDROCODONEACTIVE MOIETY6YKS4Y3WQ7HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]7
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RHYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]7
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SHYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]7
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HHYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]7
POLYVINYL ACETATEINACTIVE INGREDIENT32K497ZK2UHYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]7
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]7
SODIUM ASCORBATEINACTIVE INGREDIENTS033EH8359HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]7
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CHYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]7
SODIUM POLYSTYRENE SULFONATEINACTIVE INGREDIENT1699G8679ZHYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]7
SUCROSEINACTIVE INGREDIENTC151H8M554HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]7
TRIACETININACTIVE INGREDIENTXHX3C3X673HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]7
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]7
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEHYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [TRIS PHARMA INC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27808-086HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE (HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX) SUSPENSION, EXTENDED RELEASE [CRANBURY PHARMACEUTICALS, LLC]26Current NDC, Legacy NDC, 5 package rows20250328_25f400d9-1d6e-4d38-8f0d-98d471eba73b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087459HYDROcodone polistirex 10 MG / chlorpheniramine polistirex 8 MG in 5 mL 12HR Extended Release Oral SuspensionPSNe0010aac-2d7e-4dd3-8024-ff0c7f668b77106
108745912 HR chlorpheniramine polistirex 1.6 MG/ML / hydrocodone polistirex 2 MG/ML Extended Release SuspensionSCDe0010aac-2d7e-4dd3-8024-ff0c7f668b77106
1087459hydrocodone polistirex 10 MG / chlorpheniramine polistirex 8 MG per 5 ML 12HR Extended Release Oral SuspensionSYe0010aac-2d7e-4dd3-8024-ff0c7f668b77106
1087459HYDROcodone polistirex 10 MG / chlorpheniramine polistirex 8 MG in 5 mL 12HR Extended Release Oral SuspensionPSN03d40087-b413-4f19-af4a-e0f60b0ff542104
108745912 HR chlorpheniramine polistirex 1.6 MG/ML / hydrocodone polistirex 2 MG/ML Extended Release SuspensionSCD03d40087-b413-4f19-af4a-e0f60b0ff542104
1087459hydrocodone polistirex 10 MG / chlorpheniramine polistirex 8 MG per 5 ML 12HR Extended Release Oral SuspensionSY03d40087-b413-4f19-af4a-e0f60b0ff542104
1087459HYDROcodone polistirex 10 MG / chlorpheniramine polistirex 8 MG in 5 mL 12HR Extended Release Oral SuspensionPSNeecaa52b-f636-4ae4-a60f-d5e2503ab53b103
108745912 HR chlorpheniramine polistirex 1.6 MG/ML / hydrocodone polistirex 2 MG/ML Extended Release SuspensionSCDeecaa52b-f636-4ae4-a60f-d5e2503ab53b103
1087459hydrocodone polistirex 10 MG / chlorpheniramine polistirex 8 MG per 5 ML 12HR Extended Release Oral SuspensionSYeecaa52b-f636-4ae4-a60f-d5e2503ab53b103
1087459HYDROcodone polistirex 10 MG / chlorpheniramine polistirex 8 MG in 5 mL 12HR Extended Release Oral SuspensionPSN25f400d9-1d6e-4d38-8f0d-98d471eba73b27
108745912 HR chlorpheniramine polistirex 1.6 MG/ML / hydrocodone polistirex 2 MG/ML Extended Release SuspensionSCD25f400d9-1d6e-4d38-8f0d-98d471eba73b27
1087459hydrocodone polistirex 10 MG / chlorpheniramine polistirex 8 MG per 5 ML 12HR Extended Release Oral SuspensionSY25f400d9-1d6e-4d38-8f0d-98d471eba73b27
1087459HYDROcodone polistirex 10 MG / chlorpheniramine polistirex 8 MG in 5 mL 12HR Extended Release Oral SuspensionPSN9445fb20-9601-44e8-ac08-b27e1e2147557
108745912 HR chlorpheniramine polistirex 1.6 MG/ML / hydrocodone polistirex 2 MG/ML Extended Release SuspensionSCD9445fb20-9601-44e8-ac08-b27e1e2147557
1087459hydrocodone polistirex 10 MG / chlorpheniramine polistirex 8 MG per 5 ML 12HR Extended Release Oral SuspensionSY9445fb20-9601-44e8-ac08-b27e1e2147557

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27808-086-01278080086011 BOTTLE, UNIT-DOSE in 1 CARTON (27808-086-01) / 115 mL in 1 BOTTLE, UNIT-DOSE2015-03-060000-00-00NoNoCurrent
27808-086-0227808008602473 mL in 1 BOTTLE (27808-086-02) 473 ml2015-03-060000-00-00NoNoCurrent
27808-086-03278080086031 BOTTLE, UNIT-DOSE in 1 CARTON (27808-086-03) > 70 mL in 1 BOTTLE, UNIT-DOSE2019-10-010000-00-00NoNoCurrent