Transmucosal Fentanyl Citrate
Product Images NDC 52959-548

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Transmucosal Fentanyl Citrate (NDC 52959-548). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by H.j. Harkins Company, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Otfc Unit (Fentanyl Shadow Redel)

FDA Label Image

400 mg (Labela)

400 mg (Labela)
This is a prescription medication for Fentanyl Citrate Oral 400mcg, lot number FYC01UT, manufactured by ANESTACORP. It is advised to take as directed by a doctor or check the provided information leaflet for usual dosage instructions. The medication is similar to Actiq Oral, manufactured in Salt Lake City with NDC code 55253-071-30. The pill is identified as a lozenge. The other parts of the scanned text appear to be a repetition of the information mentioned earlier.*
FDA Label Image

600 mg (Labelb)

600 mg (Labelb)
This is a prescription bottle for Fentanyl Citrate Oral tablets. The lot number is FNCOOUT, and it was manufactured by Anestacorp. The expiration date for the medication is 09/11. The prescription is for 600mcg of Fentanyl Citrate Oral tablets, and it is a lozenge-shaped pill. The manufacturer produces a similar medication called Actiq Oral with the NDC number 55253-072-30. The medication should only be taken as directed by a doctor. The remaining text is unclear due to various errors.*
FDA Label Image

1200 mg (Labelc)

1200 mg (Labelc)
This appears to be a prescription medication for fentanyl citrate in oral form with a strength of 1200mcg. The lot number is FYLOOUT and it is manufactured by ANESTACORP. The expiration date is 08/11. It is meant to be taken as directed by a doctor and cautionary information is included. There are also pill identification details provided.*
FDA Label Image

Structural Formula (Otfc 01)

Structural Formula (Otfc 01)
Not available.*
FDA Label Image

Figure 1. Mean Serum Fentanyl Concentration (ng/ml) In Adult Subjects Comparing 4 Doses Of Otfc (Otfc 02)

Figure 1. Mean Serum Fentanyl Concentration (ng/ml) In Adult Subjects Comparing 4 Doses Of Otfc (Otfc 02)
The text seems to be a set of mathematical equations involving units of measurement such as megabyte (meg), but the text is incomplete and difficult to interpret without context. It is not possible to provide a useful description with this limited information.*
FDA Label Image

Figure 2. Pain Relief (pr) Scores (mean±sd) During The Double-blind Phase (All Patients with Evaluable Episodes on Both OTFC and Placebo (N=86))

Figure 2. Pain Relief (pr) Scores (mean±sd) During The Double-blind Phase (All Patients with Evaluable Episodes on Both OTFC and Placebo (N=86))
The text describes pain relief scores for two treatments, "otic" and "placebo" with 152 and 30 minutes of pain relief respectively. The scores were measured at 5 and 60 minutes after treatment administration. The text also mentions significant differences in pain relief between the two treatments with a p-value of less than 0.0001. The duration of the study was approximately 215 minutes from the start of OTFC administration.*
FDA Label Image

Cut Open The Package Using Scissors (Otfc 10)

FDA Label Image

Place Otfc In Your Mouth Between Your Cheeks And Gums And Actively Suck On The Medicine. (Otfc 11)

FDA Label Image

Dissolve The Medicine Under Hot Running Water (Otfc 12)

FDA Label Image

Portable Locking Pouch (Otfc 13)

FDA Label Image

Child-resistant Temporary Storage Bottle (Otfc 14)

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Information Icon (Otfc 9)

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Otfc Titration Process (Otfc Titration Process)

Otfc Titration Process (Otfc Titration Process)
The text describes a titration process for Oral Transmucosal Fentanyl Citrate to manage breakthrough pain. The initial dosage is 200 mcg and no more than 6 units can be dispensed initially. Patients should consume one unit over 15 minutes and wait for 15 more minutes. If needed, they can consume only one additional unit over 15 minutes, not taking more than two units per episode of breakthrough pain. Patients need to wait at least 4 hours before treating another episode of breakthrough pain with OTFC. They should try the 200 mcg dose for several breakthrough pain episodes. The text also provides the available dosage strengths which are 200, 400, 600, 800, 1200, and 1600 mcg.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.