Home NDC 71930-073-12 Carbamazepine
Product NDC 71930-073
Requested package NDC 71930-073-12
11-digit product format 719300073
Labeler code 71930
Product ID 71930-073_fe788fd8-8083-4201-af83-010af795d108
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carbamazepine
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Eywa Pharma Inc
Application ANDA212948
Marketing category ANDA
Marketing start 2021-10-15
Marketing end 0000-00-00
Substance CARBAMAZEPINE
Active strength 200 mg/1
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212948-001 CARBAMAZEPINE CARBAMAZEPINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2021-09-30 A212948-002 CARBAMAZEPINE CARBAMAZEPINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2021-09-30 A212948-003 CARBAMAZEPINE CARBAMAZEPINE 400MG TABLET, EXTENDED RELEASE / ORAL AB 2021-09-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 2026-08-01 22:54:32 2026-06 A212948-001 CARBAMAZEPINE 100MG TABLET, EXTENDED RELEASE / ORAL AB 2021-09-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A212948-002 CARBAMAZEPINE 200MG TABLET, EXTENDED RELEASE / ORAL AB 2021-09-30 a50c72e98297…2026-08-01 22:54:32 2026-06 A212948-003 CARBAMAZEPINE 400MG TABLET, EXTENDED RELEASE / ORAL AB 2021-09-30 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71930-073 CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [EYWA PHARMA INC] 1 Legacy NDC 20211016_48010b2b-526b-4bd6-87fd-87745c22cb8f.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71930-073-12 71930007312 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71930-073-12) 2021-10-15 0000-00-00 No No Current