FDA.reportPublic FDA data

Gabapentin

Product NDC
67877-223
11-digit product format
678770223
Labeler code
67877
Product ID
67877-223_4a89b23c-8061-4a4f-827e-62ec74d59be5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA090858
Marketing category
ANDA
Marketing start
2011-01-29
Substance
GABAPENTIN
Active strength
300 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431, 310432

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
51048710-225c-aa41-d0e7-eed095d02838Product name420250331
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
c2c26dc9-7e16-fc02-7eba-6b46ed3515eeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-223-01Gabapentin100 in 1 BOTTLECAPSULE10036
67877-223-05Gabapentin500 in 1 BOTTLECAPSULE50036
67877-223-10Gabapentin1000 in 1 BOTTLECAPSULE100036
67877-223-38Gabapentin10 in 1 BLISTER PACKCAPSULE1036
67877-223-38Gabapentin10 in 1 CARTONCAPSULE1036

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-223-01EA - Each67877-223acee3a09-aa0a-4765-8848-a0a7127ae20512012-07-24
67877-223-05EA - Each67877-223d653fdd4-0d5a-4d84-9b0f-d46b7bbb377512012-07-24
67877-223-10EA - Each67877-2234e8959c6-8fdf-43af-a839-190c443f185b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]10
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]10
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKGABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]10
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]10
GELATININACTIVE INGREDIENT2G86QN327LGABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]10
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-223GABAPENTIN CAPSULE [ASCEND LABORATORIES, LLC]36Current NDC, Legacy NDC, 5 package rows20250418_722de2a9-38b3-4518-b262-ba0d1346d0ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN03031adf-d36b-45ec-944e-dfce5a5de91a44
310431gabapentin 300 MG Oral CapsulePSN03031adf-d36b-45ec-944e-dfce5a5de91a44
310432gabapentin 400 MG Oral CapsulePSN03031adf-d36b-45ec-944e-dfce5a5de91a44
310430gabapentin 100 MG Oral CapsuleSCD03031adf-d36b-45ec-944e-dfce5a5de91a44
310431gabapentin 300 MG Oral CapsuleSCD03031adf-d36b-45ec-944e-dfce5a5de91a44
310432gabapentin 400 MG Oral CapsuleSCD03031adf-d36b-45ec-944e-dfce5a5de91a44
310431gabapentin 300 MG Oral CapsulePSN330ddc5d-c67c-33dc-e054-00144ff88e8839
310431gabapentin 300 MG Oral CapsuleSCD330ddc5d-c67c-33dc-e054-00144ff88e8839
310430gabapentin 100 MG Oral CapsulePSN722de2a9-38b3-4518-b262-ba0d1346d0ba36
310431gabapentin 300 MG Oral CapsulePSN722de2a9-38b3-4518-b262-ba0d1346d0ba36
310432gabapentin 400 MG Oral CapsulePSN722de2a9-38b3-4518-b262-ba0d1346d0ba36
310430gabapentin 100 MG Oral CapsuleSCD722de2a9-38b3-4518-b262-ba0d1346d0ba36
310431gabapentin 300 MG Oral CapsuleSCD722de2a9-38b3-4518-b262-ba0d1346d0ba36
310432gabapentin 400 MG Oral CapsuleSCD722de2a9-38b3-4518-b262-ba0d1346d0ba36
310431gabapentin 300 MG Oral CapsulePSN3e633cd0-5ee8-4a05-bcfc-0a80209bf27f28
310431gabapentin 300 MG Oral CapsuleSCD3e633cd0-5ee8-4a05-bcfc-0a80209bf27f28
310431gabapentin 300 MG Oral CapsulePSNd06380d0-c894-427e-b13e-5a8f9eb86a3419
310431gabapentin 300 MG Oral CapsuleSCDd06380d0-c894-427e-b13e-5a8f9eb86a3419
310431gabapentin 300 MG Oral CapsulePSN517fdc6d-5e72-4ee6-8471-7a7f8f4ecfe713
310432gabapentin 400 MG Oral CapsulePSN517fdc6d-5e72-4ee6-8471-7a7f8f4ecfe713
310431gabapentin 300 MG Oral CapsuleSCD517fdc6d-5e72-4ee6-8471-7a7f8f4ecfe713
310432gabapentin 400 MG Oral CapsuleSCD517fdc6d-5e72-4ee6-8471-7a7f8f4ecfe713
310431gabapentin 300 MG Oral CapsulePSNafc83432-8fce-6d2a-e053-2a95a90ae73f12
310431gabapentin 300 MG Oral CapsuleSCDafc83432-8fce-6d2a-e053-2a95a90ae73f12
310431gabapentin 300 MG Oral CapsulePSNddb3a54f-5224-4024-8804-b2a2f01d885e11
310431gabapentin 300 MG Oral CapsuleSCDddb3a54f-5224-4024-8804-b2a2f01d885e11
310430gabapentin 100 MG Oral CapsulePSN36f74fdf-0dae-47a0-a7ea-e64ac91cd88f10
310431gabapentin 300 MG Oral CapsulePSN6670a64f-7f58-479f-b285-394abb753e2e10
310431gabapentin 300 MG Oral CapsulePSN6a0a75ac-e121-477b-a9d1-d11f588afc9d10
310431gabapentin 300 MG Oral CapsulePSN36f74fdf-0dae-47a0-a7ea-e64ac91cd88f10
310432gabapentin 400 MG Oral CapsulePSN36f74fdf-0dae-47a0-a7ea-e64ac91cd88f10
310430gabapentin 100 MG Oral CapsuleSCD36f74fdf-0dae-47a0-a7ea-e64ac91cd88f10
310431gabapentin 300 MG Oral CapsuleSCD6a0a75ac-e121-477b-a9d1-d11f588afc9d10
310431gabapentin 300 MG Oral CapsuleSCD36f74fdf-0dae-47a0-a7ea-e64ac91cd88f10
310431gabapentin 300 MG Oral CapsuleSCD6670a64f-7f58-479f-b285-394abb753e2e10
310432gabapentin 400 MG Oral CapsuleSCD36f74fdf-0dae-47a0-a7ea-e64ac91cd88f10
310430gabapentin 100 MG Oral CapsulePSNbbfdedd7-2baf-4bc6-be59-548a5cf217527
310431gabapentin 300 MG Oral CapsulePSNbbfdedd7-2baf-4bc6-be59-548a5cf217527
310432gabapentin 400 MG Oral CapsulePSNbbfdedd7-2baf-4bc6-be59-548a5cf217527
310430gabapentin 100 MG Oral CapsuleSCDbbfdedd7-2baf-4bc6-be59-548a5cf217527
310431gabapentin 300 MG Oral CapsuleSCDbbfdedd7-2baf-4bc6-be59-548a5cf217527
310432gabapentin 400 MG Oral CapsuleSCDbbfdedd7-2baf-4bc6-be59-548a5cf217527
310431gabapentin 300 MG Oral CapsulePSN77d1d90d-e124-4db7-b811-754d535e579c5
310431gabapentin 300 MG Oral CapsuleSCD77d1d90d-e124-4db7-b811-754d535e579c5
310431gabapentin 300 MG Oral CapsulePSNa072d5d2-8c75-59cc-e053-2a95a90ac0cc4
310431gabapentin 300 MG Oral CapsulePSN2ef99c3d-866a-438b-a340-8beba8d4c4574
310431gabapentin 300 MG Oral CapsulePSN4eb684e5-4bae-3065-e054-00144ff88e884
310431gabapentin 300 MG Oral CapsuleSCDa072d5d2-8c75-59cc-e053-2a95a90ac0cc4
310431gabapentin 300 MG Oral CapsuleSCD4eb684e5-4bae-3065-e054-00144ff88e884
310431gabapentin 300 MG Oral CapsuleSCD2ef99c3d-866a-438b-a340-8beba8d4c4574
310430gabapentin 100 MG Oral CapsulePSN59a01ec3-97d4-c099-e053-2a91aa0af7542
310431gabapentin 300 MG Oral CapsulePSN59a01ec3-97d4-c099-e053-2a91aa0af7542
310431gabapentin 300 MG Oral CapsulePSN14b1840d-a2db-4eec-bc25-029e35b042e42
310431gabapentin 300 MG Oral CapsulePSN8a0c7a27-9419-496b-e053-2995a90ae2472
310432gabapentin 400 MG Oral CapsulePSN59a01ec3-97d4-c099-e053-2a91aa0af7542
310432gabapentin 400 MG Oral CapsulePSN14b1840d-a2db-4eec-bc25-029e35b042e42
310430gabapentin 100 MG Oral CapsuleSCD59a01ec3-97d4-c099-e053-2a91aa0af7542
310431gabapentin 300 MG Oral CapsuleSCD8a0c7a27-9419-496b-e053-2995a90ae2472
310431gabapentin 300 MG Oral CapsuleSCD59a01ec3-97d4-c099-e053-2a91aa0af7542
310431gabapentin 300 MG Oral CapsuleSCD14b1840d-a2db-4eec-bc25-029e35b042e42
310432gabapentin 400 MG Oral CapsuleSCD59a01ec3-97d4-c099-e053-2a91aa0af7542
310432gabapentin 400 MG Oral CapsuleSCD14b1840d-a2db-4eec-bc25-029e35b042e42
828348cyclobenzaprine HCl 10 MG Oral TabletPSN35dc3f7b-43d5-6203-e054-00144ff88e881
310431gabapentin 300 MG Oral CapsulePSN633e0bbe-579d-40c6-9347-d357291708e01
310431gabapentin 300 MG Oral CapsulePSNf455b415-12a2-4916-b826-246976a8af441
310431gabapentin 300 MG Oral CapsulePSN3566f528-4192-5a33-e054-00144ff8d46c1
310431gabapentin 300 MG Oral CapsulePSN35dc3f7b-43d5-6203-e054-00144ff88e881
828348cyclobenzaprine hydrochloride 10 MG Oral TabletSCD35dc3f7b-43d5-6203-e054-00144ff88e881
310431gabapentin 300 MG Oral CapsuleSCD3566f528-4192-5a33-e054-00144ff8d46c1
310431gabapentin 300 MG Oral CapsuleSCD35dc3f7b-43d5-6203-e054-00144ff88e881
310431gabapentin 300 MG Oral CapsuleSCDf455b415-12a2-4916-b826-246976a8af441
310431gabapentin 300 MG Oral CapsuleSCD633e0bbe-579d-40c6-9347-d357291708e01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-223-0167877022301100 CAPSULE in 1 BOTTLE (67877-223-01) 100 capsule2011-01-290000-00-00NoNoCurrent
67877-223-0567877022305500 CAPSULE in 1 BOTTLE (67877-223-05) 500 capsule2011-01-290000-00-00NoNoCurrent
67877-223-10678770223101000 CAPSULE in 1 BOTTLE (67877-223-10) 1000 capsule2011-01-290000-00-00NoNoCurrent
67877-223-386787702233810 BLISTER PACK in 1 CARTON (67877-223-38) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2020-03-270000-00-00NoNoCurrent