GABAPENTIN

Product NDC
71335-1454
11-digit product format
713351454
Labeler code
71335
Product ID
71335-1454_eebc392f-b112-477a-af02-59ae539281ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090705
Marketing category
ANDA
Marketing start
2017-12-05
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 54 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1454-7ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1454-5ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1454-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1454-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1454-4ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1454-6ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1454-8ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-1454-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1454-7367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1454-5367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1454-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1454-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1454-4367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1454-6367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1454-8367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-1454-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1454-7557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1454-5557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1454-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1454-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1454-4557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1454-6557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1454-8557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-1454-3557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-1454-78af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-1454-58af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-1454-18af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-1454-28af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-1454-48af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-1454-68af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-1454-88af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage71335-1454-38af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-1454-7834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-1454-5834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-1454-1834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-1454-2834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-1454-4834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-1454-6834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-1454-8834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-1454-3834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-1454-71332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-1454-51332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-1454-11332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-1454-21332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-1454-41332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-1454-61332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-1454-81332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-1454-31332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-3084e616aacf4f…
2026-09-14 22:38:342026-08A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-3084e616aacf4f…
2026-09-14 22:38:342026-08A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-3084e616aacf4f…
2026-08-18 06:07:402026-07A090705-001GABAPENTIN100MGCAPSULE / ORALAB2009-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07A090705-002GABAPENTIN300MGCAPSULE / ORALAB2009-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07A090705-003GABAPENTIN400MGCAPSULE / ORALAB2009-12-30caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090705-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090705-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A090705-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A090705-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090705-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090705-003AB1caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
1fd95278-842f-4bf9-abd5-4d9aa858d36dAvailable 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71335-1454-12024-12-23These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-22024-12-23These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-32024-12-23These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-42024-12-23These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-52024-12-23These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-62024-12-23These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-72024-12-23These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-82024-12-23These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-12024-01-30These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-22024-01-30These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-32024-01-30These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-42024-01-30These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-52024-01-30These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-62024-01-30These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-72024-01-30These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
71335-1454-82024-01-30These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1454-1GABAPENTIN90 in 1 BOTTLECAPSULE9010
71335-1454-2GABAPENTIN28 in 1 BOTTLECAPSULE2810
71335-1454-3GABAPENTIN58 in 1 BOTTLECAPSULE5810
71335-1454-4GABAPENTIN30 in 1 BOTTLECAPSULE3010
71335-1454-5GABAPENTIN60 in 1 BOTTLECAPSULE6010
71335-1454-6GABAPENTIN120 in 1 BOTTLECAPSULE12010
71335-1454-7GABAPENTIN180 in 1 BOTTLECAPSULE18010
71335-1454-8GABAPENTIN40 in 1 BOTTLECAPSULE4010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1454GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 8 package rows20241225_1fd95278-842f-4bf9-abd5-4d9aa858d36d.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-bff6-8a7113ce9f0a2026-09-01Warnings, 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
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
ndc (product): 71335-1454
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
310431gabapentin 300 MG Oral CapsulePSN1fd95278-842f-4bf9-abd5-4d9aa858d36d10
310431gabapentin 300 MG Oral CapsuleSCD1fd95278-842f-4bf9-abd5-4d9aa858d36d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1454-17133514540190 CAPSULE in 1 BOTTLE (71335-1454-1) 90 capsule2019-12-300000-00-00NoNoCurrent
71335-1454-27133514540228 CAPSULE in 1 BOTTLE (71335-1454-2) 28 capsule2024-12-100000-00-00NoNoCurrent
71335-1454-37133514540358 CAPSULE in 1 BOTTLE (71335-1454-3) 58 capsule2024-12-100000-00-00NoNoCurrent
71335-1454-47133514540430 CAPSULE in 1 BOTTLE (71335-1454-4) 30 capsule2024-12-100000-00-00NoNoCurrent
71335-1454-57133514540560 CAPSULE in 1 BOTTLE (71335-1454-5) 60 capsule2024-12-100000-00-00NoNoCurrent
71335-1454-671335145406120 CAPSULE in 1 BOTTLE (71335-1454-6) 120 capsule2024-12-100000-00-00NoNoCurrent
71335-1454-771335145407180 CAPSULE in 1 BOTTLE (71335-1454-7) 180 capsule2024-12-100000-00-00NoNoCurrent
71335-1454-87133514540840 CAPSULE in 1 BOTTLE (71335-1454-8) 40 capsule2024-12-100000-00-00NoNoCurrent