GABAPENTIN

Product NDC
68788-7024
11-digit product format
687887024
Labeler code
68788
Product ID
68788-7024_7a4c477a-2ba1-48c6-a959-b616343f8cdc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090007
Marketing category
ANDA
Marketing start
2020-06-01
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

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090007-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2011-07-21
A090007-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2011-07-21
A090007-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2011-07-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090007-001AB
A090007-002AB
A090007-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090007-002GABAPENTIN300MGCAPSULE / ORALAB2011-07-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090007-003GABAPENTIN400MGCAPSULE / ORALAB2011-07-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090007-001GABAPENTIN100MGCAPSULE / ORALAB2011-07-218072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090007-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090007-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090007-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090007-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090007-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090007-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090007-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090007-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090007-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090007-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090007-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090007-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090007-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090007-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090007-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090007-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090007-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090007-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090007-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090007-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090007-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090007-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090007-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090007-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090007-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090007-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090007-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090007-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090007-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090007-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090007-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090007-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090007-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090007-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090007-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090007-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090007-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090007-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090007-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090007-001AB18072bd15b7f6…

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 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
310431Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
11645bd6-7cfe-49b2-9292-2e4b0dbb84aeAvailable 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7024-1GABAPENTIN100 in 1 BOTTLECAPSULE1006
68788-7024-2GABAPENTIN20 in 1 BOTTLECAPSULE206
68788-7024-3GABAPENTIN30 in 1 BOTTLECAPSULE306
68788-7024-4GABAPENTIN28 in 1 BOTTLECAPSULE286
68788-7024-6GABAPENTIN60 in 1 BOTTLECAPSULE606
68788-7024-8GABAPENTIN120 in 1 BOTTLECAPSULE1206
68788-7024-9GABAPENTIN90 in 1 BOTTLECAPSULE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7024-1EA - Each68788-702424b7ab7f-9b83-40d0-96f7-75c2e13d51c412021-06-02
68788-7024-3EA - Each68788-7024788b01f6-25a5-4462-a2ae-9d0357e1833b12021-06-02
68788-7024-6EA - Each68788-7024d555010e-d11a-4e13-ae33-8b8321db44cb12021-06-02
68788-7024-8EA - Each68788-7024d4fcc8eb-2943-4e06-bfab-e93769fedd2c12021-06-02
68788-7024-9EA - Each68788-7024ba09c1f6-0f04-443d-ac4b-04e88bb7b16812021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7024GABAPENTIN CAPSULE [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 7 package rows20240509_11645bd6-7cfe-49b2-9292-2e4b0dbb84ae.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINTIME CAP LABORATORIES, INC08880902-bd44-41b6-866b-2cbad4c3f2b12026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINPD-Rx Pharmaceuticals, Inc.9814b76c-87c6-4746-b712-3269352a901b2026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINREMEDYREPACK INC.915cee37-536c-4761-bdb9-b96c7ee0f9562026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINDIRECT RX29a70e2d-d3fd-4e32-95dd-7ee721d873882026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINMARKSANS PHARMA LIMITED98bb408d-c402-4da6-8f9d-5de4833dedc42025-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.11645bd6-7cfe-49b2-9292-2e4b0dbb84ae2025-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
ndc (product): 68788-7024
GABAPENTINGABAPENTINDIRECT RXa7e45e3f-e382-32ba-e053-2a95a90a25372025-01-17Exact identifier
application applno (ANDA): 090007
application number: ANDA090007
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCb062f12c-a745-76d4-e053-2a95a90a3a1a2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINBryant Ranch Prepackc33c4d83-cc13-4104-9e24-d4cd40b17b702024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINBryant Ranch Prepacke2d9bd8c-3bb9-4945-8e61-7d2703d9008c2024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINBryant Ranch Prepack5769d849-4f27-4701-97ec-7e3ca07339d72024-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINBryant Ranch Prepack78088f6a-06a3-422f-b336-4a57a24adc162024-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.8f785189-bf66-36cc-e053-2a95a90a7cbc2024-06-19Exact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.82c0ed15-9132-657d-e053-2991aa0ae90a2024-06-14Exact identifier
application applno (ANDA): 090007
application number: ANDA090007
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLC9d1b9121-c25a-4d28-91c5-5fc72f1167f42018-07-12Exact identifier
application applno (ANDA): 090007
application number: ANDA090007
GabapentinGABAPENTINBi-Coastal Pharma International LLCe0cd96d1-b1ef-46ec-a5a3-9505b0811b8b2016-04-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN11645bd6-7cfe-49b2-9292-2e4b0dbb84ae6
310431gabapentin 300 MG Oral CapsuleSCD11645bd6-7cfe-49b2-9292-2e4b0dbb84ae6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7024-168788702401100 CAPSULE in 1 BOTTLE (68788-7024-1) 100 capsule2020-06-010000-00-00NoNoCurrent
68788-7024-26878870240220 CAPSULE in 1 BOTTLE (68788-7024-2) 20 capsule2020-06-010000-00-00NoNoCurrent
68788-7024-36878870240330 CAPSULE in 1 BOTTLE (68788-7024-3) 30 capsule2020-06-010000-00-00NoNoCurrent
68788-7024-46878870240428 CAPSULE in 1 BOTTLE (68788-7024-4) 28 capsule2020-06-010000-00-00NoNoCurrent
68788-7024-66878870240660 CAPSULE in 1 BOTTLE (68788-7024-6) 60 capsule2020-06-010000-00-00NoNoCurrent
68788-7024-868788702408120 CAPSULE in 1 BOTTLE (68788-7024-8) 120 capsule2020-06-010000-00-00NoNoCurrent
68788-7024-96878870240990 CAPSULE in 1 BOTTLE (68788-7024-9) 90 capsule2020-06-010000-00-00NoNoCurrent