Home NDC 59762-5050 GABAPENTIN
Product NDC 59762-5050
11-digit product format 597625050
Labeler code 59762
Product ID 59762-5050_f5c6e992-4771-4c56-ac1f-00ccfb88bef5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gabapentin
Dosage form SUSPENSION
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA021129
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2022-07-01
Substance GABAPENTIN
Active strength 250 mg/5mL
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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021129-001 NEURONTIN GABAPENTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021129-001 AA
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 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021129-001 NEURONTIN 250MG/5ML SOLUTION / ORAL AA RLD, RS 2000-03-02 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021129-001 7256216 2022-05-28 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021129-001 7256216*PED 2022-11-28 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021129-001 7256216 2022-05-28 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021129-001 7256216*PED 2022-11-28 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021129-001 7256216 2022-05-28 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021129-001 7256216*PED 2022-11-28 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021129-001 7256216 2022-05-28 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021129-001 7256216*PED 2022-11-28 Pediatric extension 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021129-001 7256216 2022-05-28 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021129-001 7256216*PED 2022-11-28 Pediatric extension bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021129-001 7256216 2022-05-28 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021129-001 7256216*PED 2022-11-28 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021129-001 7256216 2022-05-28 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021129-001 7256216*PED 2022-11-28 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021129-001 7256216 2022-05-28 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021129-001 7256216*PED 2022-11-28 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021129-001 7256216 2022-05-28 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021129-001 7256216*PED 2022-11-28 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021129-001 7256216 2022-05-28 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021129-001 7256216*PED 2022-11-28 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021129-001 7256216 2022-05-28 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021129-001 7256216*PED 2022-11-28 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021129-001 7256216 2022-05-28 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021129-001 7256216*PED 2022-11-28 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021129-001 7256216 2022-05-28 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021129-001 7256216*PED 2022-11-28 Pediatric extension ea99ee380514…2023-01-26 05:58 UTC 2023-01 N021129-001 7256216 2022-05-28 Drug product 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N021129-001 7256216*PED 2022-11-28 Pediatric extension 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021129-001 7256216 2022-05-28 Drug product 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021129-001 7256216*PED 2022-11-28 Pediatric extension 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021129-001 7256216 2022-05-28 Drug product f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021129-001 7256216*PED 2022-11-28 Pediatric extension f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021129-001 7256216 2022-05-28 Drug product e64feba35796…2022-09-29 23:25 UTC 2022-09 N021129-001 7256216*PED 2022-11-28 Pediatric extension e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021129-001 7256216 2022-05-28 Drug product cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021129-001 7256216*PED 2022-11-28 Pediatric extension cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base GABAPENTIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GABAPENTIN 250 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6CW7F3G59X Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59762-5050-7 GABAPENTIN 470 mL in 1 BOTTLE, PLASTIC SUSPENSION 470 36 59762-5050-7 GABAPENTIN 1 in 1 CARTON SUSPENSION 1 36
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GABAPENTIN ACTIVE INGREDIENT 6CW7F3G59X GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] 18 GABAPENTIN ACTIVE MOIETY 6CW7F3G59X GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] 18 CANDELILLA WAX INACTIVE INGREDIENT WL0328HX19 GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] 18 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] 18 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] 18 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] 18 GELATIN INACTIVE INGREDIENT 2G86QN327L GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] 18 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] 18 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] 18 LACTOSE INACTIVE INGREDIENT J2B2A4N98G GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] 18 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] 18 POLOXAMER 407 INACTIVE INGREDIENT TUF2IVW3M2 GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] 18 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] 18 TALC INACTIVE INGREDIENT 7SEV7J4R1U GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] 18 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] 18 WATER INACTIVE INGREDIENT 059QF0KO0R GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] 18 XYLITOL INACTIVE INGREDIENT VCQ006KQ1E GABAPENTIN CAPSULE GABAPENTIN TABLET, FILM COATED GABAPENTIN SUSPENSION [GREENSTONE LLC] 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-5050 GABAPENTIN SUSPENSION [MYLAN PHARMACEUTICALS INC.] 35 Current NDC, Legacy NDC, 2 package rows 20250503_cff7de45-148b-4e96-88fd-6052bf75b5f7.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 · 3 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59762-5050-1 59762505001 1 BOTTLE in 1 CARTON (59762-5050-1) > 470 mL in 1 BOTTLE 1 bottle 2020-01-14 0000-00-00 No No Current 59762-5050-7 59762505007 1 BOTTLE, PLASTIC in 1 CARTON (59762-5050-7) / 470 mL in 1 BOTTLE, PLASTIC 2022-07-01 0000-00-00 No No Current