gabapentin

Product NDC
16571-868
11-digit product format
165710868
Labeler code
16571
Product ID
16571-868_2e493243-47c0-460e-bea9-4ed0261adf90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA207099
Marketing category
ANDA
Marketing start
2022-08-01
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
A207099-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2017-03-24
A207099-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2017-03-24
A207099-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2017-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207099-001AB
A207099-002AB
A207099-003AB

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 UTC2026-02A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207099-002GABAPENTIN300MGCAPSULE / ORALAB2017-03-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207099-003GABAPENTIN400MGCAPSULE / ORALAB2017-03-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207099-001GABAPENTIN100MGCAPSULE / ORALAB2017-03-248072bd15b7f6…

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 UTC2026-02A207099-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207099-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207099-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207099-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207099-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207099-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207099-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207099-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207099-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207099-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207099-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207099-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207099-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207099-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207099-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207099-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207099-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207099-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207099-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207099-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207099-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207099-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207099-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207099-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207099-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207099-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207099-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207099-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207099-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207099-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207099-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207099-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207099-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207099-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207099-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207099-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207099-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207099-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207099-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207099-001AB18072bd15b7f6…

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 · 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
969cccfc-e56a-49da-9d36-47c0c3fad7f8Available 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-868-01gabapentin100 in 1 BOTTLECAPSULE1003
16571-868-03gabapentin30 in 1 BOTTLECAPSULE303
16571-868-10gabapentin1000 in 1 BOTTLECAPSULE10003
16571-868-50gabapentin500 in 1 BOTTLECAPSULE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-868-01EA - Each16571-868556b71b2-bdb3-45aa-9562-ed7d6de2a31512022-08-04
16571-868-10EA - Each16571-868e36200fe-2856-49c8-a813-d5624f79ac5b12022-08-04
16571-868-50EA - Each16571-8684b586652-6755-44e2-93b8-d520fed89c8f12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-868GABAPENTIN CAPSULE [RISING PHARMA HOLDINGS, INC.]2Current NDC, Legacy NDC, 4 package rows20250529_969cccfc-e56a-49da-9d36-47c0c3fad7f8.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
gabapentinGABAPENTINREMEDYREPACK INC.32169228-e85c-4dbf-8722-cd2f8e0f5d1a2026-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacy2bc65375-77b8-1e50-e063-6294a90acf8f2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
gabapentinGABAPENTINProficient Rx LPc7674ea5-276b-4bb3-821b-4ac05c9e64e62026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
GabapentinGABAPENTINDirect_Rx0b286fd1-8179-d87a-e063-6294a90a2f232026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
gabapentinGABAPENTINCoupler LLC47cd25f6-e123-9aaf-e063-6394a90aeedd2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
gabapentinGABAPENTINNorthwind Health Company, LLC471b2d32-0cbd-aade-e063-6394a90a16962025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
gabapentinGABAPENTINREMEDYREPACK INC.4a975ebe-ae0a-446a-8a3d-2ca325e28f932025-09-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
gabapentinGABAPENTINCoupler LLC3eeda97d-c3cd-65cd-e063-6394a90aae8b2025-09-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
GabapentinGABAPENTINDirect_Rx2cb1ad6d-d389-4564-e063-6394a90a36442025-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
gabapentinGABAPENTINRising Pharma Holdings, Inc.969cccfc-e56a-49da-9d36-47c0c3fad7f82025-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
ndc (product): 16571-868
GabapentinGABAPENTINProficient Rx LP64a65366-8577-48f2-9f8e-0332f126d3c12025-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099
GabapentinGABAPENTINEpic Pharma, LLC030e656a-e384-49ac-830f-32140c18112d2019-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207099
application number: ANDA207099

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN2bc65375-77b8-1e50-e063-6294a90acf8f4
310431gabapentin 300 MG Oral CapsulePSN2cb1ad6d-d389-4564-e063-6394a90a36444
310431gabapentin 300 MG Oral CapsuleSCD2bc65375-77b8-1e50-e063-6294a90acf8f4
310431gabapentin 300 MG Oral CapsuleSCD2cb1ad6d-d389-4564-e063-6394a90a36444
310430gabapentin 100 MG Oral CapsulePSN969cccfc-e56a-49da-9d36-47c0c3fad7f83
310431gabapentin 300 MG Oral CapsulePSN969cccfc-e56a-49da-9d36-47c0c3fad7f83
310432gabapentin 400 MG Oral CapsulePSN969cccfc-e56a-49da-9d36-47c0c3fad7f83
310430gabapentin 100 MG Oral CapsuleSCD969cccfc-e56a-49da-9d36-47c0c3fad7f83
310431gabapentin 300 MG Oral CapsuleSCD969cccfc-e56a-49da-9d36-47c0c3fad7f83
310432gabapentin 400 MG Oral CapsuleSCD969cccfc-e56a-49da-9d36-47c0c3fad7f83
310431gabapentin 300 MG Oral CapsulePSN471b2d32-0cbd-aade-e063-6394a90a16962
310431gabapentin 300 MG Oral CapsuleSCD471b2d32-0cbd-aade-e063-6394a90a16962
310431gabapentin 300 MG Oral CapsulePSN64a65366-8577-48f2-9f8e-0332f126d3c11
310431gabapentin 300 MG Oral CapsuleSCD64a65366-8577-48f2-9f8e-0332f126d3c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-868-0116571086801100 CAPSULE in 1 BOTTLE (16571-868-01) 100 capsule2022-08-010000-00-00NoNoCurrent
16571-868-031657108680330 CAPSULE in 1 BOTTLE (16571-868-03) 30 capsule2022-08-010000-00-00NoNoCurrent
16571-868-10165710868101000 CAPSULE in 1 BOTTLE (16571-868-10) 1000 capsule2022-08-010000-00-00NoNoCurrent
16571-868-5016571086850500 CAPSULE in 1 BOTTLE (16571-868-50) 500 capsule2022-08-010000-00-00NoNoCurrent