GABAPENTIN

Product NDC
69097-813
Requested package NDC
69097-813-12
11-digit product format
690970813
Labeler code
69097
Product ID
69097-813_fdeea2da-e306-45d8-a27a-e8be090319ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA090705
Marketing category
ANDA
Marketing start
2016-06-29
Substance
GABAPENTIN
Active strength
100 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
A090705-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2009-12-30
A090705-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2009-12-30
A090705-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2009-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090705-001AB
A090705-002AB
A090705-003AB

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 UTC2026-02A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-308072bd15b7f6…

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 UTC2026-02A090705-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090705-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090705-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090705-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090705-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090705-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090705-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090705-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090705-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090705-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090705-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090705-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090705-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090705-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090705-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090705-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090705-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090705-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090705-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090705-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN100 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
9e4eca9c-6a2c-4ede-a252-1a27094bf594Available 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-813-07GABAPENTIN100 in 1 BOTTLECAPSULE1008
69097-813-12GABAPENTIN500 in 1 BOTTLECAPSULE5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-813-07EA - Each69097-81341918388-50b5-421b-8b9f-d6e7b9a0884312016-07-19
69097-813-12EA - Each69097-813d64e3fe7-bba5-49c6-822a-4688c820f10e12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-813GABAPENTIN CAPSULE [CIPLA USA INC.]7Current NDC, Legacy NDC, 2 package rows20241115_9e4eca9c-6a2c-4ede-a252-1a27094bf594.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINREMEDYREPACK INC.1373587e-807a-462a-bff6-8a7113ce9f0a2025-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINExelan Pharmaceuticals, Inc.41d1ead3-046e-4abf-ae0a-cb126a1f58482025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINCipla USA Inc.9e4eca9c-6a2c-4ede-a252-1a27094bf5942025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
ndc (package): 69097-813-12
ndc (product): 69097-813
ndc11 (package): 69097081312
GABAPENTINGABAPENTINBryant Ranch Prepack6e7f602a-2c5f-4651-a228-5fc5bf2492052024-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINBryant Ranch Prepack1fd95278-842f-4bf9-abd5-4d9aa858d36d2024-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINBryant Ranch Prepack97a1d45d-d5b3-4be7-9b3a-cb6f80f602912024-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINAsclemed USA, Inc.45039bba-7a96-450c-95be-83a3aa4fcbd22020-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINProficient Rx LP4bae5032-f634-4d1e-b672-8a7e2bd6a5fa2019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINProficient Rx LP92c4d589-533b-4fe4-833f-dd68cc1f7e662019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLCa900bafb-8f49-4a01-ba7f-4fb228ec02532018-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLC6702ed8f-4aaf-46fa-bf39-db75154aa44c2018-10-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090705
application number: ANDA090705

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN96dd98f8-55a3-2a5e-e053-2995a90a5cdc10
310430gabapentin 100 MG Oral CapsuleSCD96dd98f8-55a3-2a5e-e053-2995a90a5cdc10
310430gabapentin 100 MG Oral CapsulePSN783af1df-dbcc-41c9-bbd6-fcb3d28381539
310431gabapentin 300 MG Oral CapsulePSN783af1df-dbcc-41c9-bbd6-fcb3d28381539
310430gabapentin 100 MG Oral CapsuleSCD783af1df-dbcc-41c9-bbd6-fcb3d28381539
310431gabapentin 300 MG Oral CapsuleSCD783af1df-dbcc-41c9-bbd6-fcb3d28381539
310430gabapentin 100 MG Oral CapsulePSN9e4eca9c-6a2c-4ede-a252-1a27094bf5948
310431gabapentin 300 MG Oral CapsulePSN9e4eca9c-6a2c-4ede-a252-1a27094bf5948
310432gabapentin 400 MG Oral CapsulePSN9e4eca9c-6a2c-4ede-a252-1a27094bf5948
310430gabapentin 100 MG Oral CapsuleSCD9e4eca9c-6a2c-4ede-a252-1a27094bf5948
310431gabapentin 300 MG Oral CapsuleSCD9e4eca9c-6a2c-4ede-a252-1a27094bf5948
310432gabapentin 400 MG Oral CapsuleSCD9e4eca9c-6a2c-4ede-a252-1a27094bf5948
310430gabapentin 100 MG Oral CapsulePSN97a1d45d-d5b3-4be7-9b3a-cb6f80f602917
310430gabapentin 100 MG Oral CapsuleSCD97a1d45d-d5b3-4be7-9b3a-cb6f80f602917
310430gabapentin 100 MG Oral CapsulePSN1373587e-807a-462a-bff6-8a7113ce9f0a4
310430gabapentin 100 MG Oral CapsulePSN4bae5032-f634-4d1e-b672-8a7e2bd6a5fa4
310430gabapentin 100 MG Oral CapsulePSN1cee4f32-b1f6-4a8e-bcb1-64f4cdab7a2f4
310430gabapentin 100 MG Oral CapsuleSCD4bae5032-f634-4d1e-b672-8a7e2bd6a5fa4
310430gabapentin 100 MG Oral CapsuleSCD1cee4f32-b1f6-4a8e-bcb1-64f4cdab7a2f4
310430gabapentin 100 MG Oral CapsuleSCD1373587e-807a-462a-bff6-8a7113ce9f0a4
310430gabapentin 100 MG Oral CapsulePSN828cb73e-536a-48db-acf3-52e36b7e8c533
310430gabapentin 100 MG Oral CapsuleSCD828cb73e-536a-48db-acf3-52e36b7e8c533

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-813-1269097081312500 CAPSULE in 1 BOTTLE (69097-813-12) 500 capsule2016-06-290000-00-00NoNoCurrent