# 0641-1496-35 · Promethazine Hydrochloride Injection · Hikma Pharmaceuticals USA, Inc. — FDA drug shortage duration tracker

For 0641-1496-35 · Promethazine Hydrochloride Injection · Hikma Pharmaceuticals USA, Inc., package ndc is 0641-1496-35; generic name is Promethazine Hydrochloride Injection; manufacturer is Hikma Pharmaceuticals USA, Inc; status is Current; availability now is Unavailable, recorded from its source on 2026-09-01.

- **Package NDC:** 0641-1496-35 _(verified: appears in the quote below)_
- **Generic name:** Promethazine Hydrochloride Injection _(verified: appears in the quote below)_
- **Manufacturer:** Hikma Pharmaceuticals USA, Inc. _(verified: appears in its own passage below)_
- **Status:** Current _(verified: appears in its own passage below)_
- **Availability now:** Unavailable _(verified: appears in the quote below)_
- **FDA note:** Estimated recovery: TBD _(verified: appears in the quote below)_
- **Initial posting date:** 11/21/2023 _(verified: appears in the quote below)_
- **Last update date:** 08/13/2026 _(verified: appears in its own passage below)_
- **Days in shortage:** 1015 _(our reading, not quoted from the source)_
- **Reason for shortage:** Other _(verified: appears in its own passage below)_
- **Dosage form:** Injection _(verified: appears in its own passage below)_
- **Therapeutic category:** Analgesia/Addiction _(verified: appears in its own passage below)_

## What the source says

> "initial_posting_date": "11/21/2023", "package_ndc": "0641-1496-35", "generic_name": "Promethazine Hydrochloride Injection", "contact_info": "800-631-2174", "availability": "Unavailable", "related_info": "Estimated recovery: TBD"

## Where each value comes from

This source states these in separate places, so each value is shown with the passage that states it.

### Manufacturer

> "update_date": "08/13/2026", "therapeutic_category": [ "Analgesia/Addiction", "Gastroenterology", "Pediatric", "Pulmonary/Allergy" ], "dosage_form": "Injection", "presentation": "Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-1496-35)", "company_name": "Hikma Pharmaceuticals USA, Inc.", "shortage_reason": "Other", "status": "Current"

### Status

> "update_date": "08/13/2026", "therapeutic_category": [ "Analgesia/Addiction", "Gastroenterology", "Pediatric", "Pulmonary/Allergy" ], "dosage_form": "Injection", "presentation": "Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-1496-35)", "company_name": "Hikma Pharmaceuticals USA, Inc.", "shortage_reason": "Other", "status": "Current"

### Last update date

> "update_date": "08/13/2026", "therapeutic_category": [ "Analgesia/Addiction", "Gastroenterology", "Pediatric", "Pulmonary/Allergy" ], "dosage_form": "Injection", "presentation": "Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-1496-35)", "company_name": "Hikma Pharmaceuticals USA, Inc.", "shortage_reason": "Other", "status": "Current"

### Reason for shortage

> "update_date": "08/13/2026", "therapeutic_category": [ "Analgesia/Addiction", "Gastroenterology", "Pediatric", "Pulmonary/Allergy" ], "dosage_form": "Injection", "presentation": "Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-1496-35)", "company_name": "Hikma Pharmaceuticals USA, Inc.", "shortage_reason": "Other", "status": "Current"

### Dosage form

> "update_date": "08/13/2026", "therapeutic_category": [ "Analgesia/Addiction", "Gastroenterology", "Pediatric", "Pulmonary/Allergy" ], "dosage_form": "Injection", "presentation": "Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-1496-35)", "company_name": "Hikma Pharmaceuticals USA, Inc.", "shortage_reason": "Other", "status": "Current"

### Therapeutic category

> "update_date": "08/13/2026", "therapeutic_category": [ "Analgesia/Addiction", "Gastroenterology", "Pediatric", "Pulmonary/Allergy" ], "dosage_form": "Injection", "presentation": "Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-1496-35)", "company_name": "Hikma Pharmaceuticals USA, Inc.", "shortage_reason": "Other", "status": "Current"

## The same source also states

> "initial_posting_date": "11/21/2023", "package_ndc": "0641-1496-35", "generic_name": "Promethazine Hydrochloride Injection", "contact_info": "800-631-2174", "availability": "Unavailable", "related_info": "Additional lots will be available in the October 2026 timeframe. Product will be made available as it is released."

Source: https://api.fda.gov/drug/shortages.json?search=company_name%3A%22Hikma%20Pharmaceuticals%20USA,%20Inc.%22+AND+generic_name%3A%22Promethazine%20Hydrochloride%20Injection%22+AND+status%3A%22Current%22&limit=1000

## Source

- https://api.fda.gov/drug/shortages.json?search=company_name%3A%22Hikma%20Pharmaceuticals%20USA,%20Inc.%22+AND+generic_name%3A%22Promethazine%20Hydrochloride%20Injection%22+AND+status%3A%22Current%22&limit=1000

Last verified: 2026-09-01. Review by: 2026-09-04.
Part of [FDA drug shortage duration tracker](https://referencesource.org/drug-shortage-duration-tracker/).