GABAPENTIN

Product NDC
71610-621
11-digit product format
716100621
Labeler code
71610
Product ID
71610-621_bc931d95-28ae-405b-ad93-e1fe0b51eab9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA214957
Marketing category
ANDA
Marketing start
2021-10-01
Substance
GABAPENTIN
Active strength
600 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], 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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214957-001GABAPENTINGABAPENTIN600MGTABLET / ORALAB12021-10-01
A214957-002GABAPENTINGABAPENTIN800MGTABLET / ORALAB12021-10-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A214957-001AB1
A214957-002AB1

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 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-01caaa826d4ba7…
2026-08-18 06:07:402026-07A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214957-001GABAPENTIN600MGTABLET / ORALAB12021-10-018072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214957-002GABAPENTIN800MGTABLET / ORALAB12021-10-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214957-001GABAPENTIN600MGTABLET / ORALAB2021-10-015c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214957-002GABAPENTIN800MGTABLET / ORALAB2021-10-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214957-001GABAPENTIN600MGTABLET / ORALAB2021-10-015d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A214957-002GABAPENTIN800MGTABLET / ORALAB2021-10-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214957-001GABAPENTIN600MGTABLET / ORALAB2021-10-014b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A214957-002GABAPENTIN800MGTABLET / ORALAB2021-10-014b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214957-001GABAPENTIN600MGTABLET / ORALAB2021-10-01bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A214957-002GABAPENTIN800MGTABLET / ORALAB2021-10-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214957-001GABAPENTIN600MGTABLET / ORALAB2021-10-01782e0a99824c…
2021-12-28 21:50 UTC2021-12A214957-002GABAPENTIN800MGTABLET / ORALAB2021-10-01782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A214957-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A214957-002AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214957-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214957-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214957-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214957-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214957-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214957-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214957-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214957-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214957-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214957-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214957-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214957-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214957-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214957-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214957-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214957-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214957-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214957-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214957-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A214957-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214957-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214957-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214957-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214957-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214957-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214957-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214957-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A214957-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214957-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214957-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214957-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A214957-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214957-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A214957-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214957-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A214957-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214957-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A214957-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN600 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
310433Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7f579665-afb7-4227-98c1-2eafee650504Available 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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-621-15GABAPENTIN15 in 1 BOTTLETABLET152
71610-621-30GABAPENTIN30 in 1 BOTTLETABLET302
71610-621-45GABAPENTIN45 in 1 BOTTLETABLET452
71610-621-53GABAPENTIN60 in 1 BOTTLETABLET602
71610-621-60GABAPENTIN90 in 1 BOTTLETABLET902
71610-621-70GABAPENTIN120 in 1 BOTTLETABLET1202
71610-621-73GABAPENTIN135 in 1 BOTTLETABLET1352
71610-621-80GABAPENTIN180 in 1 BOTTLETABLET1802
71610-621-92GABAPENTIN270 in 1 BOTTLETABLET2702
71610-621-94GABAPENTIN360 in 1 BOTTLETABLET3602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-621-15EA - Each71610-621184da3fb-cb48-444e-9d11-41dad6fe05d412022-04-06
71610-621-30EA - Each71610-621a505c27b-dc28-4c35-8c62-a4358829476412022-02-07
71610-621-45EA - Each71610-62139890082-48c2-4552-b07a-0b96e5f271b212022-02-07
71610-621-53EA - Each71610-62147bef506-2c20-4306-8a5d-aea25826115d12022-04-06
71610-621-60EA - Each71610-621b7511c9c-7e2d-4658-81dc-65a05b34dcb812022-02-07
71610-621-70EA - Each71610-621393d02df-efd7-40fd-9c40-aef5c78e62f612022-04-06
71610-621-73EA - Each71610-621570c0127-8df4-4680-8639-006e56cdcbd912022-02-07
71610-621-80EA - Each71610-6213bd040c5-6c52-4840-ac27-6c2ad5dc5fb012022-02-07
71610-621-92EA - Each71610-621840653d5-c973-459f-a92c-b785dffb14a412022-02-07
71610-621-94EA - Each71610-62117be1f09-0444-452e-9773-20672d48728212022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-621GABAPENTIN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 10 package rows20220302_7f579665-afb7-4227-98c1-2eafee650504.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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINBryant Ranch Prepackc9f0cceb-b24e-4526-b873-fedd877d6bc62026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINSt. Mary's Medical Park Pharmacy07f07d15-ee91-8c2a-e063-6394a90a46242026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.180b99a5-7d3d-4ee5-a0cc-1ae0ede646ee2026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.35da078b-0da0-4757-a6c4-a9144c37e8e12026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.38119f2e-33b3-4c3c-99b7-9335d8d280d42026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINCoupler LLC500ee820-0378-6fc9-e063-6394a90a109c2026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINST. MARY'S MEDICAL PARK PHARMACY4ddc1342-5c83-f562-e063-6294a90a29ba2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINBryant Ranch Prepack2e331641-ec26-4d76-b16b-a9863c767afe2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.60b46f6d-efbc-487a-b672-b20df8b44cc42026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINProficient Rx LPda8438e1-755b-4195-baa7-464f3d9ee5bd2025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINCamber Pharmaceuticals, Inc.9ead7825-d11b-4e00-8533-328d097b8f832025-08-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINExelan Pharmaceuticals, Inc.a88edb00-2189-4c8d-9dd7-9fe1571775cc2025-08-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINXLCare Pharmaceuticals, Inc.707ed63a-67ca-4a62-9cbe-cdeb5c4ab5062025-08-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GabapentinGABAPENTINDirect_Rxed9c501c-24e4-da89-e053-2a95a90a64c62025-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINAsclemed USA, Inc.1f1203f4-2184-4e13-e063-6394a90a43302025-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINProficient Rx LP7fcce531-bf7c-43b6-bea9-8f0602842c532025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINCoupler LLC3133c863-d33b-c9d7-e063-6294a90ae8982025-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.febf610e-e088-4797-e053-6294a90a3eb52025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GabapentinGABAPENTINDirect_Rxfbc05ceb-2e69-3c37-e053-6394a90ac4f42024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957
GABAPENTINGABAPENTINClinical Solutions Wholesale, LLC934fefae-b895-427c-8798-4c5462b1ecc22024-04-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214957
application number: ANDA214957

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN7f579665-afb7-4227-98c1-2eafee6505042
310433gabapentin 600 MG Oral TabletSCD7f579665-afb7-4227-98c1-2eafee6505042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-621-157161006211515 TABLET in 1 BOTTLE (71610-621-15) 15 tablet2022-01-240000-00-00NoNoCurrent
71610-621-307161006213030 TABLET in 1 BOTTLE (71610-621-30) 30 tablet2021-12-020000-00-00NoNoCurrent
71610-621-457161006214545 TABLET in 1 BOTTLE (71610-621-45) 45 tablet2021-12-020000-00-00NoNoCurrent
71610-621-537161006215360 TABLET in 1 BOTTLE (71610-621-53) 60 tablet2022-01-240000-00-00NoNoCurrent
71610-621-607161006216090 TABLET in 1 BOTTLE (71610-621-60) 90 tablet2021-12-020000-00-00NoNoCurrent
71610-621-7071610062170120 TABLET in 1 BOTTLE (71610-621-70) 120 tablet2022-01-240000-00-00NoNoCurrent
71610-621-7371610062173135 TABLET in 1 BOTTLE (71610-621-73) 135 tablet2021-12-020000-00-00NoNoCurrent
71610-621-8071610062180180 TABLET in 1 BOTTLE (71610-621-80) 180 tablet2021-12-170000-00-00NoNoCurrent
71610-621-9271610062192270 TABLET in 1 BOTTLE (71610-621-92) 270 tablet2021-12-020000-00-00NoNoCurrent
71610-621-9471610062194360 TABLET in 1 BOTTLE (71610-621-94) 360 tablet2022-01-240000-00-00NoNoCurrent