Home NDC 70518-4167-0 CARBAMAZEPINE
Product NDC 70518-4167
Requested package NDC 70518-4167-0
11-digit product format 705184167
Labeler code 70518
Product ID 70518-4167_5a1c7623-864a-cb55-e063-6294a90aec05
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CARBAMAZEPINE
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA218221
Marketing category ANDA
Marketing start 2024-08-25
Substance CARBAMAZEPINE
Active strength 200 mg/1
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A218221-001 CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218221-001 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.
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 2026-09-14 22:38:34 2026-08 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218221-001 CARBAMAZEPINE 200MG TABLET / ORAL AB 2024-02-16 a50c72e98297…
Observed Orange Book normalized TE history# 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 CARBAMAZEPINE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARBAMAZEPINE 200 mg/1
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308979 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 70518-4167-0 CARBAMAZEPINE 30 in 1 BLISTER PACK TABLET 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-4167 CARBAMAZEPINE TABLET [REMEDYREPACK INC.] 3 Current NDC, 1 package rows 20250504_5f9535b1-ff6a-41b3-bbb2-efcf8fbacf4c.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4167-0 70518416700 30 TABLET in 1 BLISTER PACK (70518-4167-0) 30 tablet 2024-08-25 No No Current