GABAPENTIN

Product NDC
49483-607
11-digit product format
494830607
Labeler code
49483
Product ID
49483-607_39a5daea-e195-c00b-e063-6394a90a42a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
TIME CAP LABORATORIES, INC
Application
ANDA090007
Marketing category
ANDA
Marketing start
2015-12-30
Substance
GABAPENTIN
Active strength
400 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
GABAPENTIN400 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310430Internal RxNorm lookup
310431Internal RxNorm lookup
310432Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
08880902-bd44-41b6-866b-2cbad4c3f2b1Available 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
49483-607-01GABAPENTIN100 in 1 BOTTLECAPSULE10010
49483-607-10GABAPENTIN1000 in 1 BOTTLECAPSULE100010
49483-607-50GABAPENTIN500 in 1 BOTTLECAPSULE50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-607-01EA - Each49483-607eb970281-cd52-4169-aca1-b9bd9a199b3212016-05-16
49483-607-10EA - Each49483-6079f6ecc9f-cc58-487c-8575-3e1c94a4072f12021-06-02
49483-607-50EA - Each49483-607f8a18fb2-a6fb-49c3-9f9b-6a71e4d1f42c12016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49483-607GABAPENTIN CAPSULE GABAPENTIN CAPSULE [TIME CAP LABORATORIES, INC]9Current NDC, Legacy NDC, 3 package rows20241013_08880902-bd44-41b6-866b-2cbad4c3f2b1.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
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
GABAPENTINGABAPENTINTIME CAP LABORATORIES, INC08880902-bd44-41b6-866b-2cbad4c3f2b12025-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
ndc (product): 49483-607
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.11645bd6-7cfe-49b2-9292-2e4b0dbb84ae2025-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090007
application number: ANDA090007
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
310430gabapentin 100 MG Oral CapsulePSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310432gabapentin 400 MG Oral CapsulePSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310434gabapentin 800 MG Oral TabletPSNa7e45e3f-e382-32ba-e053-2a95a90a253715
310430gabapentin 100 MG Oral CapsuleSCDa7e45e3f-e382-32ba-e053-2a95a90a253715
310432gabapentin 400 MG Oral CapsuleSCDa7e45e3f-e382-32ba-e053-2a95a90a253715
310434gabapentin 800 MG Oral TabletSCDa7e45e3f-e382-32ba-e053-2a95a90a253715
310430gabapentin 100 MG Oral CapsulePSN08880902-bd44-41b6-866b-2cbad4c3f2b110
310431gabapentin 300 MG Oral CapsulePSN08880902-bd44-41b6-866b-2cbad4c3f2b110
310432gabapentin 400 MG Oral CapsulePSN08880902-bd44-41b6-866b-2cbad4c3f2b110
310430gabapentin 100 MG Oral CapsuleSCD08880902-bd44-41b6-866b-2cbad4c3f2b110
310431gabapentin 300 MG Oral CapsuleSCD08880902-bd44-41b6-866b-2cbad4c3f2b110
310432gabapentin 400 MG Oral CapsuleSCD08880902-bd44-41b6-866b-2cbad4c3f2b110
310432gabapentin 400 MG Oral CapsulePSN915cee37-536c-4761-bdb9-b96c7ee0f9564
310432gabapentin 400 MG Oral CapsuleSCD915cee37-536c-4761-bdb9-b96c7ee0f9564
310432gabapentin 400 MG Oral CapsulePSNb552a38a-5ada-4e79-a5ed-c785dcf5b5683
310432gabapentin 400 MG Oral CapsuleSCDb552a38a-5ada-4e79-a5ed-c785dcf5b5683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49483-607-0149483060701100 CAPSULE in 1 BOTTLE (49483-607-01) 100 capsule2015-12-300000-00-00NoNoCurrent
49483-607-10494830607101000 CAPSULE in 1 BOTTLE (49483-607-10) 1000 capsule2021-04-170000-00-00NoNoCurrent
49483-607-5049483060750500 CAPSULE in 1 BOTTLE (49483-607-50) 500 capsule2015-12-300000-00-00NoNoCurrent