FDA.reportPublic FDA data

ConZip

Product NDC
68025-073
11-digit product format
680250073
Labeler code
68025
Product ID
68025-073_50c36ee9-b6f1-4f50-a276-cfbfa49ba588
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Vertical Pharmaceuticals, LLC
Application
NDA022370
Marketing category
NDA
Marketing start
2011-09-20
Substance
TRAMADOL HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ConZip
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRAMADOL HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9N7R477WCK
Rxcui1148478, 1148482, 1148485, 1148487, 1148489, 1148491

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
43d017e1-6ae6-7555-71d1-c249236d6f26Product name420251117
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
c563c906-2606-457c-bb1b-5a623daed55bProduct name120210511
43a9f8f9-34aa-8ae8-719e-5489454f7720Product name520200123
abd2f6f2-3fa7-4571-af8a-d67f89bdcb75Product name120190927
377068df-225f-7318-a910-a1987cdfa361Product name320170608
9457302e-0ca3-d9ff-0863-1b24b6107218Product name120140508
d5c49867-1fe9-7a44-3319-814417011d51Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68025-073-30ConZip30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68025-073-30EA - Each68025-07352668c07-2836-4b6b-89dc-a70a6affe37912014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKCONZIP (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]3
TRAMADOLACTIVE MOIETY39J1LGJ30JCONZIP (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCONZIP (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]3
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8CONZIP (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCONZIP (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]3
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)INACTIVE INGREDIENTP2OM2Q86BICONZIP (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCONZIP (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]3
GELATININACTIVE INGREDIENT2G86QN327LCONZIP (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CONZIP (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCONZIP (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CONZIP (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCONZIP (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]3
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQCONZIP (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]3
SHELLACINACTIVE INGREDIENT46N107B71OCONZIP (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCONZIP (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]3
SUCROSE STEARATEINACTIVE INGREDIENT274KW0O50MCONZIP (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UCONZIP (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCONZIP (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68025-073CONZIP (TRAMADOL HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]13Current NDC, Legacy NDC, 1 package rows20240103_a65b4d05-3a1c-4aa1-848a-d20ac9aaf62f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148482ConZip 100 MG 24HR Extended Release Oral CapsulePSNa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f14
1148487ConZip 200 MG 24HR Extended Release Oral CapsulePSNa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f14
1148491ConZip 300 MG 24HR Extended Release Oral CapsulePSNa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f14
1148478traMADol HCl 100 MG 24HR Extended Release Oral CapsulePSNa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f14
1148485traMADol HCl 200 MG 24HR Extended Release Oral CapsulePSNa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f14
1148489traMADol HCl 300 MG 24HR Extended Release Oral CapsulePSNa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f14
114848224 HR tramadol hydrochloride 100 MG Extended Release Oral Capsule [ConZip]SBDa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f14
114848724 HR tramadol hydrochloride 200 MG Extended Release Oral Capsule [ConZip]SBDa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f14
114849124 HR tramadol hydrochloride 300 MG Extended Release Oral Capsule [ConZip]SBDa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f14
114847824 HR tramadol hydrochloride 100 MG Extended Release Oral CapsuleSCDa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f14
114848524 HR tramadol hydrochloride 200 MG Extended Release Oral CapsuleSCDa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f14
114848924 HR tramadol hydrochloride 300 MG Extended Release Oral CapsuleSCDa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f14
114848224 HR ConZip 100 MG Extended Release Oral CapsuleSYa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f14
114848724 HR ConZip 200 MG Extended Release Oral CapsuleSYa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f14
114849124 HR ConZip 300 MG Extended Release Oral CapsuleSYa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f14
1148482ConZip 100 MG 24 HR Extended Release Oral CapsuleSYa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f14
1148487ConZip 200 MG 24 HR Extended Release Oral CapsuleSYa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f14
1148491ConZip 300 MG 24 HR Extended Release Oral CapsuleSYa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f14
1148485tramadol hydrochloride 200 MG 24 HR Extended Release Oral CapsuleSYa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f14
1148489tramadol hydrochloride 300 MG 24 HR Extended Release Oral CapsuleSYa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68025-073-306802500733030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68025-073-30) 2011-09-200000-00-00NoNoCurrent