Home NDC 0078-0508 Tegretol
Product NDC 0078-0508
11-digit product format 000780508
Labeler code 0078
Product ID 0078-0508_2765f762-2f4e-4a2b-ac10-cf8149d9a38e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name carbamazepine
Dosage form SUSPENSION
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA018927
Marketing category NDA
Marketing start 1987-12-18
Substance CARBAMAZEPINE
Active strength 100 mg/5mL
Pharmacologic classes Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N018927-001 TEGRETOL CARBAMAZEPINE 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018927-001 AB
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 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018927-001 TEGRETOL 100MG/5ML SUSPENSION / ORAL AB RLD, RS 1987-12-18 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tegretol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARBAMAZEPINE 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 33CM23913M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199378 Internal RxNorm lookup 308971 Internal RxNorm lookup 308972 Internal RxNorm lookup 308976 Internal RxNorm lookup 308979 Internal RxNorm lookup 402505 Internal RxNorm lookup 402506 Internal RxNorm lookup 866303 Internal RxNorm lookup 866305 Internal RxNorm lookup 866307 Internal RxNorm 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 0078-0508-83 Tegretol 450 mL in 1 BOTTLE SUSPENSION 450 36
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CARBAMAZEPINE ACTIVE INGREDIENT 33CM23913M TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 CARBAMAZEPINE ACTIVE MOIETY 33CM23913M TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 DEXTRATES INACTIVE INGREDIENT G263MI44RU TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 GELATIN INACTIVE INGREDIENT 2G86QN327L TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 MANNITOL INACTIVE INGREDIENT 3OWL53L36A TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 SORBITOL INACTIVE INGREDIENT 506T60A25R TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 SUCROSE INACTIVE INGREDIENT C151H8M554 TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 WATER INACTIVE INGREDIENT 059QF0KO0R TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE TEGRETOL (CARBAMAZEPINE) TABLET, CHEWABLE TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0508 TEGRETOL (CARBAMAZEPINE) SUSPENSION TEGRETOL (CARBAMAZEPINE) TABLET TEGRETOL XR (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION] 34 Current NDC, Legacy NDC, 1 package rows 20250122_8d409411-aa9f-4f3a-a52c-fbcb0c3ec053.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tegretol CARBAMAZEPINE Novartis Pharmaceuticals Corporation 8d409411-aa9f-4f3a-a52c-fbcb0c3ec053 2026-07-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 018927 application number: NDA018927 ndc (product): 0078-0508
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0078-0508-83 00078050883 450 mL in 1 BOTTLE (0078-0508-83) 450 ml 1987-12-18 0000-00-00 No No Current