Gabapentin

Product NDC
42192-608
11-digit product format
421920608
Labeler code
42192
Product ID
42192-608_42b42328-c02f-5413-e063-6394a90ace67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
SOLUTION
Route
ORAL
Labeler
Acella Pharmaceuticals, LLC
Application
ANDA076403
Marketing category
ANDA
Marketing start
2012-10-01
Substance
GABAPENTIN
Active strength
250 mg/5mL
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076403-001GABAPENTINGABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A076403-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-013f01610625f2…
2019-09-15 20:21 UTC2019-09A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076403-001GABAPENTIN250MG/5MLSOLUTION / ORALAA2012-05-01cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076403-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076403-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076403-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076403-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076403-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076403-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076403-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076403-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076403-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076403-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076403-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076403-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076403-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076403-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076403-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076403-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076403-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076403-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076403-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076403-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076403-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A076403-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076403-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076403-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076403-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A076403-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076403-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076403-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076403-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076403-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076403-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076403-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076403-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076403-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076403-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076403-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076403-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076403-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076403-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076403-001AA1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN250 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6CW7F3G59XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283523Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42192-608-05Gabapentin5 mL in 1 CUP, UNIT-DOSESOLUTION513
42192-608-06Gabapentin6 mL in 1 CUP, UNIT-DOSESOLUTION613
42192-608-16Gabapentin470 mL in 1 BOTTLESOLUTION47013
42192-608-40Gabapentin6 mL in 1 CUP, UNIT-DOSESOLUTION613
42192-608-40Gabapentin40 in 1 BOXSOLUTION4013
42192-608-45Gabapentin5 mL in 1 CUP, UNIT-DOSESOLUTION513
42192-608-45Gabapentin40 in 1 BOXSOLUTION4013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42192-608-05ML - Milliliter42192-608bf473aa3-aa15-4a8c-b6f6-ba3080ac465e12021-06-02
42192-608-06ML - Milliliter42192-60859c4be8d-d1a7-48d7-abe3-8ea63b64211712020-03-10
42192-608-16ML - Milliliter42192-608fb5393fc-3901-44da-933a-3777eccf4cd212013-02-13
42192-608-40ML - Milliliter42192-608f2c872c1-bdd0-4150-83ad-06ebc534b38312020-03-10
42192-608-45ML - Milliliter42192-608e0c05083-0af4-4c2f-b2eb-3a171e06071012021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGABAPENTIN SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGABAPENTIN SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGABAPENTIN SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN SOLUTION [ACELLA PHARMACEUTICALS, LLC]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EGABAPENTIN SOLUTION [ACELLA PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42192-608GABAPENTIN SOLUTION [ACELLA PHARMACEUTICALS, LLC]11Current NDC, Legacy NDC, 7 package rows20241011_3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa2.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINAcella Pharmaceuticals, LLC3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa22025-11-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076403
application number: ANDA076403
ndc (product): 42192-608
GabapentinGABAPENTINBryant Ranch Prepack5134369d-c7f6-4569-a425-d50e5a5d694f2025-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076403
application number: ANDA076403
GabapentinGABAPENTINATLANTIC BIOLOGICALS CORP.5969f1a8-d6d5-4967-add5-4e2492354d7b2025-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076403
application number: ANDA076403

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283523gabapentin 250 MG in 5 mL Oral SolutionPSN5134369d-c7f6-4569-a425-d50e5a5d694f102
283523gabapentin 50 MG/ML Oral SolutionSCD5134369d-c7f6-4569-a425-d50e5a5d694f102
283523gabapentin 250 MG per 5 ML Oral SolutionSY5134369d-c7f6-4569-a425-d50e5a5d694f102
283523gabapentin 300 MG per 6 ML Oral SolutionSY5134369d-c7f6-4569-a425-d50e5a5d694f102
283523gabapentin 500 MG per 10 ML Oral SolutionSY5134369d-c7f6-4569-a425-d50e5a5d694f102
283523gabapentin 250 MG in 5 mL Oral SolutionPSN3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa213
283523gabapentin 50 MG/ML Oral SolutionSCD3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa213
283523gabapentin 250 MG per 5 ML Oral SolutionSY3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa213
283523gabapentin 300 MG per 6 ML Oral SolutionSY3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa213
283523gabapentin 500 MG per 10 ML Oral SolutionSY3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa213
283523gabapentin 250 MG in 5 mL Oral SolutionPSN5969f1a8-d6d5-4967-add5-4e2492354d7b7
283523gabapentin 50 MG/ML Oral SolutionSCD5969f1a8-d6d5-4967-add5-4e2492354d7b7
283523gabapentin 250 MG per 5 ML Oral SolutionSY5969f1a8-d6d5-4967-add5-4e2492354d7b7
283523gabapentin 300 MG per 6 ML Oral SolutionSY5969f1a8-d6d5-4967-add5-4e2492354d7b7
283523gabapentin 500 MG per 10 ML Oral SolutionSY5969f1a8-d6d5-4967-add5-4e2492354d7b7
283523gabapentin 250 MG in 5 mL Oral SolutionPSN2b4d316c-1234-41d7-831d-645b3dd6e4482
283523gabapentin 50 MG/ML Oral SolutionSCD2b4d316c-1234-41d7-831d-645b3dd6e4482
283523gabapentin 250 MG per 5 ML Oral SolutionSY2b4d316c-1234-41d7-831d-645b3dd6e4482
283523gabapentin 300 MG per 6 ML Oral SolutionSY2b4d316c-1234-41d7-831d-645b3dd6e4482
283523gabapentin 500 MG per 10 ML Oral SolutionSY2b4d316c-1234-41d7-831d-645b3dd6e4482

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42192-608-05421920608055 mL in 1 CUP, UNIT-DOSE (42192-608-05) 5 ml2019-08-160000-00-00NoNoCurrent
42192-608-06421920608066 mL in 1 CUP, UNIT-DOSE (42192-608-06) 6 ml2019-08-160000-00-00NoNoCurrent
42192-608-1642192060816470 mL in 1 BOTTLE (42192-608-16) 470 ml2012-10-010000-00-00NoNoCurrent
42192-608-404219206084040 CUP, UNIT-DOSE in 1 BOX (42192-608-40) / 6 mL in 1 CUP, UNIT-DOSE2019-08-160000-00-00NoNoCurrent
42192-608-454219206084540 CUP, UNIT-DOSE in 1 BOX (42192-608-45) / 5 mL in 1 CUP, UNIT-DOSE2021-05-050000-00-00NoNoCurrent