NDC codes

FDA NDC Directory
Product NDC (as listed)51991-034Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51991-0034Add 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
51991-034-065199100340660 TABLET in 1 BOTTLE (51991-034-06)Marketed from Mar 19, 2026

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Milnacipran Hydrochloride
Generic name (nonproprietary)
milnacipran hydrochloride
Active ingredients
Milnacipran hydrochloride — 12.5 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205071
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 51991-034_fa3779b3-31c7-4cc1-be71-0330e7d58c86SPL ID fa3779b3-31c7-4cc1-be71-0330e7d58c86SPL set ID e39b4890-99e4-4e48-9f45-978d5ac9f402RxCUI 833135, 833141, 833144, 833147UNII RNZ43O5WW5

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

N451991003406 followed by a unit qualifier and the quantity

Package 51991-0034-06. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Milnacipran hydrochloride tablets are indicated for the management of fibromyalgia. Milnacipran hydrochloride tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4) ]. Milnacipran hydrochloride tablets are selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia ( 1 ). Milnacipran hydrochloride tablets are not approved for use in pediatric patients ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205071

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 205071
ProductStrengthForm · routeLabelerProduct NDC
Milnacipran HydrochlorideMilnacipran hydrochloride 50 mg/1TabletOralBreckenridge Pharmaceutical, Inc.51991-036
Milnacipran HydrochlorideMilnacipran hydrochloride 100 mg/1TabletOralBreckenridge Pharmaceutical, Inc.51991-037
Milnacipran HydrochlorideMilnacipran hydrochloride 25 mg/1TabletOralBreckenridge Pharmaceutical, Inc.51991-876

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