Home NDC 0781-1392 Haloperidol
Product NDC 0781-1392
11-digit product format 007811392
Labeler code 0781
Product ID 0781-1392_efbe4986-95cd-4ddb-8120-c6feacd2017f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Haloperidol
Dosage form TABLET
Route ORAL
Labeler Sandoz Inc
Application ANDA071207
Marketing category ANDA
Marketing start 1986-11-17
Marketing end 2020-12-31
Substance HALOPERIDOL
Active strength 1 mg/1
Pharmacologic classes Typical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog .
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 2022-04-04 05:41 UTC 2022-04 A071207-001 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071207-001 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071207-001 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071207-001 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071207-001 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071207-001 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071207-001 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071207-001 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071207-001 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071207-001 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071207-001 HALOPERIDOL 1MG TABLET / ORAL AB 1986-11-17 ea99ee380514…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HALOPERIDOL ACTIVE INGREDIENT J6292F8L3D HALOPERIDOL TABLET [SANDOZ INC] 12 HALOPERIDOL ACTIVE MOIETY J6292F8L3D HALOPERIDOL TABLET [SANDOZ INC] 12 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K HALOPERIDOL TABLET [SANDOZ INC] 12 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B HALOPERIDOL TABLET [SANDOZ INC] 12 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G HALOPERIDOL TABLET [SANDOZ INC] 12 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD HALOPERIDOL TABLET [SANDOZ INC] 12 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 HALOPERIDOL TABLET [SANDOZ INC] 12 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HALOPERIDOL TABLET [SANDOZ INC] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HALOPERIDOL TABLET [SANDOZ INC] 12 POVIDONE INACTIVE INGREDIENT FZ989GH94E HALOPERIDOL TABLET [SANDOZ INC] 12 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HALOPERIDOL TABLET [SANDOZ INC] 12 HALOPERIDOL ACTIVE INGREDIENT J6292F8L3D HALOPERIDOL TABLET [CARDINAL HEALTH] 2 HALOPERIDOL ACTIVE INGREDIENT J6292F8L3D HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 HALOPERIDOL ACTIVE MOIETY J6292F8L3D HALOPERIDOL TABLET [CARDINAL HEALTH] 2 HALOPERIDOL ACTIVE MOIETY J6292F8L3D HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K HALOPERIDOL TABLET [CARDINAL HEALTH] 2 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B HALOPERIDOL TABLET [CARDINAL HEALTH] 2 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G HALOPERIDOL TABLET [CARDINAL HEALTH] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD HALOPERIDOL TABLET [CARDINAL HEALTH] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 HALOPERIDOL TABLET [CARDINAL HEALTH] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HALOPERIDOL TABLET [CARDINAL HEALTH] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HALOPERIDOL TABLET [CARDINAL HEALTH] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E HALOPERIDOL TABLET [CARDINAL HEALTH] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HALOPERIDOL TABLET [CARDINAL HEALTH] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HALOPERIDOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 2 HALOPERIDOL ACTIVE INGREDIENT J6292F8L3D HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS] 1 HALOPERIDOL ACTIVE INGREDIENT J6292F8L3D HALOPERIDOL TABLET [DISPENSING SOLUTIONS, INC.] 1 HALOPERIDOL ACTIVE MOIETY J6292F8L3D HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS] 1 HALOPERIDOL ACTIVE MOIETY J6292F8L3D HALOPERIDOL TABLET [DISPENSING SOLUTIONS, INC.] 1 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS] 1 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G HALOPERIDOL TABLET [DISPENSING SOLUTIONS, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 HALOPERIDOL TABLET [DISPENSING SOLUTIONS, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HALOPERIDOL TABLET [DISPENSING SOLUTIONS, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 HALOPERIDOL TABLET [DISPENSING SOLUTIONS, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E HALOPERIDOL TABLET [DISPENSING SOLUTIONS, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HALOPERIDOL TABLET [MAJOR PHARMACEUTICALS] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HALOPERIDOL TABLET [DISPENSING SOLUTIONS, INC.] 1
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