NDC codes

FDA NDC Directory
Product NDC (as listed)44911-0513Labeler and product segments. Claims need a package NDC.
Product NDC at billing width44911-0513Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
44911-0513-1449110513014491105130130 mL in 1 BOTTLE, DROPPER (44911-0513-1)Marketed from Oct 3, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Otoflam HPSuffix: HP
Generic name (nonproprietary)
belladonna, conium maculatum, dulcamara, ferrum phosphoricum, hepar sulphuris calcareum, kali bichromicum, mercurius solubilis, pulsatilla (pratensis), silicea, chamomilla.
Active ingredients
Atropa belladonna whole — 30 [hp_X]/mLConium maculatum flowering top — 30 [hp_X]/mLSolanum dulcamara top — 30 [hp_X]/mLFerrosoferric phosphate — 30 [hp_X]/mLCalcium sulfide — 30 [hp_X]/mLPotassium dichromate — 30 [hp_X]/mLMercurius solubilis — 30 [hp_X]/mLPulsatilla pratensis whole — 30 [hp_X]/mLSilicon dioxide — 30 [hp_X]/mLMatricaria chamomilla whole — 30 [hp_C]/mL
Dosage form
Liquid
Route
Oral
Labeler
Energique, Inc.NDC labeler code 44911
Product type
Over-the-counter drug
Marketing category
Unapproved homeopathic
Marketing start
Listing expires
Identifiers
Product ID 44911-0513_b1b1bae2-148d-43f0-a7fe-f35c19a1bd31SPL ID b1b1bae2-148d-43f0-a7fe-f35c19a1bd31SPL set ID 76c6b494-43d1-4508-bea4-4f9026b4a5faUNII DSV74G1P2J, Q28R5GF371, KPS1B1162N, 91GQH8I5F7, 1MBW07J51Q, T4423S18FM, 324Y4038G2, 8E272251DI, ETJ7Z6XBU4, G0R4UBI2ZZ

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N444911051301 followed by a unit qualifier and the quantity

Package 44911-0513-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE: May temporarily relieve ear pain and swelling.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 44911-0513

What is NDC 44911-0513?
44911-0513 is the product NDC for Otoflam HP, Atropa belladonna whole 30 [hp_X]/mL + 9 more ingredients liquid, listed with the FDA by Energique, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Otoflam HP (Belladonna, Conium Maculatum, Dulcamara, Ferrum Phosphoricum, Hepar Sulphuris Calcareum, Kali Bichromicum, Mercurius Solubilis, Pulsatilla (Pratensis), Silicea, Chamomilla.).
What is the active ingredient?
Atropa belladonna whole, Conium maculatum flowering top, Solanum dulcamara top, Ferrosoferric phosphate, Calcium sulfide, Potassium dichromate, Mercurius solubilis, Pulsatilla pratensis whole, Silicon dioxide, Matricaria chamomilla whole.
Who is the labeler?
Energique, Inc., NDC labeler code 44911. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Otoflam HP?
1 other product NDC are listed under this name. See all Otoflam HP NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Otoflam HP NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Otoflam HPbelladonna, conium maculatum, dulcamara, hepar sulphuris calcareum, kali bichromicum, mercurius solubilis, pulsatilla (vulgaris), silicea, chamomillaAtropa belladonna 30 [hp_X]/mL + 8 more ingredientsLiquidOralBioActive Nutritional, Inc.43857-003443857-0034-01

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