FDA.reportPublic FDA data

Prochlorperazine Edisylate

Product NDC
70860-778
Requested package NDC
70860-778-02
11-digit product format
708600778
Labeler code
70860
Product ID
70860-778_0a1bce3b-675f-420b-a8fd-a93bde270753
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prochlorperazine edisylate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Athenex Pharmaceutical Division, LLC.
Application
ANDA040540
Marketing category
ANDA
Marketing start
2018-11-08
Marketing end
0000-00-00
Substance
PROCHLORPERAZINE EDISYLATE
Active strength
5 mg/mL
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70860-77870860-778-02DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040540-001PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2004-05-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A040540-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A040540-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2004-05-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040540-001AP1a50c72e98297…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70860-778-022024-03-05C16284748780-11030e365-60d2-111a-e063-dadaa90a10e2Prochlorperazine Edisylate Injection, USP (For Deep Intramuscular or Intravenous Injection) (NOT FOR SUBCUTANEOUS USE)
70860-778-022024-01-30C16284748780-11030e365-60d2-111a-e063-dadaa90a10e2Prochlorperazine Edisylate Injection, USP (For Deep Intramuscular or Intravenous Injection) (NOT FOR SUBCUTANEOUS USE)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-778-02ML - Milliliter70860-778d1340562-ec6b-4abd-aff3-876d72de5f5d12018-12-13
70860-778-10ML - Milliliter70860-77845bbeb04-2bf8-4c44-84e8-4777a001322212018-12-13
70860-778-41ML - Milliliter70860-7781fe9460f-03ef-4d0c-bad6-3330e603b5a912018-12-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70860-778-027086007780210 VIAL in 1 CARTON (70860-778-02) > 2 mL in 1 VIAL (70860-778-41) 10 vial2018-11-080000-00-00NoNoCurrent